---
case_studies:
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- 405ddf49-26b3-4dd7-90d8-e75c9bb3066a
- a4772b79-2fa7-493a-b2cb-b27e0f533955
- a5e3f49f-d0d1-4d5e-8787-2447c1a5272d
- d40db497-be40-4fd6-8a60-abe35b4c2d3b
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- 4da60185-95f2-4c8a-8b7c-eb5207099ada
- f0783a53-613a-41f8-aed1-12aa2d6f21b9
- 0a34f626-a373-4bcf-9bce-68d80918c103
- 6c43d793-b0c3-407c-a698-8d0f6ab1a113
- 3554ddc2-8662-4e4e-848f-b6a80bc535ef
- 599965fd-8341-43f2-b7a3-662ff4e1a8b4
- 195786d0-6dad-49cb-afad-5e19b6462db7
- 7b3cf1e3-360f-4cb5-b0be-befc42a38bc8
- 141bd5b7-a754-80c4-8e9a-fa24807a2e59
- 143bd5b7-a754-80ce-9ff8-d5ce8e646fa5
- 145bd5b7-a754-80ee-aa5f-dcb427458972
- 14abd5b7-a754-80dc-ba3b-f361c0bcfd49
- 23ebd5b7-a754-8094-8b32-c848608f43d1
- 344bd5b7-a754-80dd-b412-dd7cd7259821
description: Innolitics is a medical device software development company. We design,
  build, and FDA-clear SaMD and SiMD products. 70+ devices since 2012. IEC 62304 and
  ISO 13485 compliant. US-based team.
featured: true
is_solution: false
service_name: Software Development
sort_order: 1
title: Medical Device Software Development
widget_icon: []
---

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# Medical Device Software Development

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Innolitics is a **medical device software development company** that helps you design, develop, and FDA-clear your medical device software. Our fully US-based team of engineers and regulatory consultants has built software for **over 70 medical devices** since 2012 — from AI-powered diagnostics to embedded imaging systems. Whether you need a dedicated project team, staff augmentation, or a full end-to-end software partner, we deliver IEC 62304 compliant, submission-ready code and documentation.

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<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Partner with Innolitics</a></div>

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![](/img/services/Software_Development-75147d89b2924bd0b3e3e209f8122fa8.png)

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## Who We Work With

We work on both **Software as a Medical Device (SaMD)** and **Software in a Medical Device (SiMD)** products.

We are proud to partner with a diverse array of clients, from visionary startups to industry-leading Fortune 500 companies. Typical clients include:

<div class="grid grid-cols-1 sm:grid-cols-2 gap-3 my-3">

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![](/img/services/Software_Development-127bd5b7a75480c0864dc4a8b8e63792.svg)

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Clinician Founders

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<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0 text-center sm:text-left bg-white rounded border-solid border p-4 font-bold text-sm [&_p]:text-primary sm:text-base border-primary/30" markdown="1">

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![](/img/services/Software_Development-127bd5b7a754807d90bdd9fa36b6c01a.svg)

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Venture-Backed Startups

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</div>

<div class="grid grid-cols-1 sm:grid-cols-2 gap-3 my-3">

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![](/img/services/Software_Development-127bd5b7a754801e9ca0c43c4ca83595.svg)

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Medical Device Companies

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<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0 text-center sm:text-left bg-white rounded border-solid border p-4 font-bold text-sm [&_p]:text-primary sm:text-base border-primary/30" markdown="1">

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![](/img/services/Software_Development-127bd5b7a754803f9ea5d7a98291d4d1.svg)

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Academic Research Institutions

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<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Let’s Meet</a></div>

## Why Choose Innolitics for Medical Device Software Development

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<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0" markdown="1">

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- **All we do is medical-device software development**
- Developed software for **over 70 medical devices** since 2012
- Cybersecurity expertise in **threat modeling, security risk management, SBOMs** and more
- Deep knowledge of medical-device standards, including **DICOM and HL7**
- We comply with **ISO 13485** and **IEC 62304**

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- We can write all the **software and cybersecurity documents needed for** **FDA submissions**
- Four **AI/ML and image-processing experts** on our team, including three PhDs and two MDs
- Six **FDA regulatory consultants** on staff
- [Medtech OS](https://innolitics.com/services/medtech-os/) and its **checklists, templates, and** **tooling** is built on the experience FDA clearing more than 50 **SaMD** and **SiMD** products

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<h2 id="engagement-models" class="start-bg text-primary text-center !mt-16 sm:!mt-40 relative -z-10 after:block after:absolute after:-top-8 sm:after:-top-16 after:h-[150vh] after:-z-10 after:w-screen after:left-1/2 after:right-1/2 after:-ml-[50vw] after:-mr-[50vw] after:bg-gradient-to-b after:from-muted_bg after:to-white after:to-90% [&.text-center+p]:text-center">Engagement Models</h2>

We engage with our clients in three different ways:

<details class="[&_span.chevron-down-button_svg]:open:rotate-180 bg-white my-5 py-4 px-6 rounded border-solid border border-gray"><summary class="flex flex-row-reverse justify-between items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="chevron-down-button text-center text-xl font-medium ml-2 mt-0"><svg xmlns="http://www.w3.org/2000/svg" width="42" height="42" fill="none" stroke="#2D3F86" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" class="transition-transform relative top-1 w-7 sm:w-8 h-auto" viewBox="0 0 24 24"><path stroke="none" d="M0 0h24v24H0z"/><path d="m6 9 6 6 6-6"/></svg></span><h3 class="text-heading m-0">Project-Based</h3></summary><div class="mr-2 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>We help you complete software development projects with a defined
scope. For example:</p>
<ul>
<li>Custom Web-Based GUIs</li>
<li>Medical Imaging Software</li>
<li>SMART on FHIR apps</li>
<li>Adding DICOM or HL7 Integrations to existing products</li>
<li>Independent Software V&amp;V for submissions</li>
<li>Refactoring Existing Software</li>
<li>Training New AI/ML Models</li>
<li>Image Processing Algorithm Development</li>
<li>Translating Research Code into Compliant Code</li>
<li>Developing Companion Apps</li>
</ul>
<p>This engagement model works well when the scope of the project is
understood. We will work with you to define a scope, cost-estimate, and
timeline estimate for the project.</p>
<p><img
src="/img/services/Software_Development-127bd5b7a7548039b16df94350270cdf.png" /></p>
<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Get a Quote your Software Project</a></div>
</div></details>
<details class="[&_span.chevron-down-button_svg]:open:rotate-180 bg-white my-5 py-4 px-6 rounded border-solid border border-gray"><summary class="flex flex-row-reverse justify-between items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="chevron-down-button text-center text-xl font-medium ml-2 mt-0"><svg xmlns="http://www.w3.org/2000/svg" width="42" height="42" fill="none" stroke="#2D3F86" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" class="transition-transform relative top-1 w-7 sm:w-8 h-auto" viewBox="0 0 24 24"><path stroke="none" d="M0 0h24v24H0z"/><path d="m6 9 6 6 6-6"/></svg></span><h3 class="text-heading m-0">Staff Augmentation</h3></summary><div class="mr-2 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>We provide experienced <strong>medical-device software
engineers</strong> to augment your in-house team.</p>
<p>Our engineers are trained on the FDA regulations and guidance and can
work within your QMS.</p>
<p>We provide engineers at either half-time or full-time and at varying
levels of experience. We can also increase and decrease staffing levels
as needed.</p>
<p>This engagement model is appropriate if you have poorly scoped work
or need ongoing support. Often, after completing a project-based
engagement, our clients request to retain the engineers they work with
in an on-going basis.</p>
<p><img
src="/img/services/Software_Development-134bd5b7a75480fea969c0fffbaf0e44.png" /></p>
<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Augment your Team with Full- or Half-Time Engineers</a></div>
</div></details>
<details class="[&_span.chevron-down-button_svg]:open:rotate-180 bg-white my-5 py-4 px-6 rounded border-solid border border-gray"><summary class="flex flex-row-reverse justify-between items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="chevron-down-button text-center text-xl font-medium ml-2 mt-0"><svg xmlns="http://www.w3.org/2000/svg" width="42" height="42" fill="none" stroke="#2D3F86" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" class="transition-transform relative top-1 w-7 sm:w-8 h-auto" viewBox="0 0 24 24"><path stroke="none" d="M0 0h24v24H0z"/><path d="m6 9 6 6 6-6"/></svg></span><h3 class="text-heading m-0">End-to-End Software Partner</h3></summary><div class="mr-2 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>We can be your full-service software partner for a new medical
product. This engagement model is often appropriate for:</p>
<ul>
<li>Busy Clinician Founders</li>
<li>SiMD Startups without an in-house Software Team</li>
<li>Companies Fully Outsourcing Development of a new Software as a
Medical Device Product</li>
</ul>
<p><strong>We will work with your team to design, develop, validate, FDA
clear, and maintain the software for your new medical-device
product.</strong></p>
<p>If you don’t have a regulatory consultant, we can also be your
regulatory partner. Read more about our regulatory services <a
href="https://innolitics.com/services/regulatory/">here</a>.</p>
<p><img
src="/img/services/Software_Development-134bd5b7a75480789ad0fd78c9bbb659.png" /></p>
<p><img
src="/img/services/Software_Development-134bd5b7a75480c99f2fcc12b6520921.png" /></p>
<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Partner with Innolitics</a></div>
</div></details>

## Medical Device Software Applications We Build

Our expertise spans across a broad range of medical device software applications. We specialize in creating solutions that are not only innovative but also compliant and secure, ensuring they meet the highest industry standards.

We have experience developing a variety of medical device software applications, including:

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<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0 text-center sm:text-left bg-white rounded border-solid border p-4 font-bold text-sm [&_p]:text-primary sm:text-base border-gray shadow-sm" markdown="1">

<div markdown="1">

![](/img/services/Software_Development-127bd5b7a75480328003ebc3d43fd7d2.svg)

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<div markdown="1">

Digital Diagnostics

</div>

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<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0 text-center sm:text-left bg-white rounded border-solid border p-4 font-bold text-sm [&_p]:text-primary sm:text-base border-gray shadow-sm" markdown="1">

<div markdown="1">

![](/img/services/Software_Development-127bd5b7a75480bb9263c85b26984d95.svg)

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<div markdown="1">

Medical Image Viewers

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<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0 text-center sm:text-left bg-white rounded border-solid border p-4 font-bold text-sm [&_p]:text-primary sm:text-base border-gray shadow-sm" markdown="1">

<div markdown="1">

![](/img/services/Software_Development-127bd5b7a75480c28f03dc70c3d801a5.svg)

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<div markdown="1">

Software for IVDs and LDTs

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![](/img/services/Software_Development-127bd5b7a754803eb3c6f280c5fb3d49.svg)

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Mobile Medical Apps

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![](/img/services/Software_Development-127bd5b7a7548092b03cc32fffdf1e9f.svg)

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Digital Therapeutics (DTx)

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</div>

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<div markdown="1">

![](/img/services/Software_Development-127bd5b7a754809fbec2f8c232671986.svg)

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Software Accessories

</div>

</div>

</div>

## Our Medical Device Software Development Process

Every medical device software project we take on follows our proven development process, built on IEC 62304 and refined across 70+ products:

1. **Requirements, Architecture & Threat Modeling** — We define software requirements, system architecture, and threat models with regulatory traceability built in from day one.
2. **Iterative Development** — Agile sprints with continuous integration, verification testing, and design history documentation produced alongside the code.
3. **Cybersecurity & Risk Management** — Security risk management, SBOM generation, and cybersecurity documentation integrated throughout development per FDA cybersecurity guidance — not bolted on at the end.
4. **Verification, Validation & Penetration Testing** — Rigorous V&V including unit testing, integration testing, system-level validation, and penetration testing against your intended use and security requirements.
5. **Submission-Ready Deliverables** — Complete software and cybersecurity documentation package ready for your IDE, 510(k), De Novo, or PMA submission.

<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Discuss Your Project</a></div>

<h2 id="explore-selected-software-projects" class="text-center [&.text-center+p]:text-center">Explore Selected Software Projects</h2>

Explore a few of our [many case studies](https://innolitics.com/portfolio/?tags=software-development):





<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Add Your Device to the List</a></div>
<h2 id="what-our-customers-say" class="start-bg text-primary text-center !mt-16 sm:!mt-40 relative -z-10 after:block after:absolute after:-top-8 sm:after:-top-16 after:h-[150vh] after:-z-10 after:w-screen after:left-1/2 after:right-1/2 after:-ml-[50vw] after:-mr-[50vw] after:bg-gradient-to-b after:from-muted_bg after:to-white after:to-90% [&.text-center+p]:text-center">What Our Customers Say</h2>






## The Clinical Perspective

Our engineering work is guided by a clinical perspective. One of our founders is an MD and we have a broad network of clinicians we leverage. We have experience in the following clinical areas:

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![](/img/services/Software_Development-129bd5b7a754804a8909c07cef7b81e6.svg)

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Radiology

</div>

</div>

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<div markdown="1">

![](/img/services/Software_Development-129bd5b7a75480a58afbfcb72c266e11.svg)

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Digital Health

</div>

</div>

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![](/img/services/Software_Development-129bd5b7a75480fbae65d51860fc17a8.svg)

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Radiation Oncology

</div>

</div>

<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0 text-center sm:text-left bg-white rounded border-solid border p-4 font-bold text-sm [&_p]:text-primary sm:p-2 sm:text-xs leading-normal border-gray shadow-sm" markdown="1">

<div markdown="1">

![](/img/services/Software_Development-129bd5b7a7548067a85ef94ff3df3d8b.svg)

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<div markdown="1">

InVitro Diagnostics (IVDs)

</div>

</div>

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<div markdown="1">

![](/img/services/Software_Development-129bd5b7a75480aba073cac55e63898f.svg)

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<div markdown="1">

Dental

</div>

</div>

</div>

<div class="grid grid-cols-1 sm:grid-cols-5 gap-2 my-2">

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<div markdown="1">

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Cardiology

</div>

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</div>

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![](/img/services/Software_Development-129bd5b7a75480c09865ee1fe1130d67.svg)

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Pre-Clinical

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</div>

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Ear Nose and Throat

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</div>

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Neurology

</div>

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</div>

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<div class="[&_div.cta-wrapper]:my-4 [&_div.cta-wrapper]:sm:text-left [&_h1]:text-center [&_h1]:sm:text-left [&_h2]:text-center [&_h2]:sm:text-left [&_h2]:mt-0 text-center sm:text-left bg-white rounded border-solid border p-4 font-bold text-sm [&_p]:text-primary sm:p-2 sm:text-xs leading-normal border-gray shadow-sm" markdown="1">

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Gastroenterology and Urology

</div>

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</div>

## Regulatory Compliance

Our ISO 13485 compliant quality management system and development process adheres to the highest standards of quality and compliance, including IEC 62304 for medical device software, ISO 14971 for risk management, and AAMI TIR 57 for cybersecurity. Whether working within our quality management system or integrating with yours, we guarantee excellence and compliance at every stage.

![](/img/services/Software_Development-d6d37a6d0bdb47bfb44dd106e6cd09f7.png)

<details class="[&_span.chevron-down-button_svg]:open:rotate-180 bg-white my-5 py-4 px-6 rounded border-solid border border-gray"><summary class="flex flex-row-reverse justify-between items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="chevron-down-button text-center text-xl font-medium ml-2 mt-0"><svg xmlns="http://www.w3.org/2000/svg" width="42" height="42" fill="none" stroke="#2D3F86" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" class="transition-transform relative top-1 w-7 sm:w-8 h-auto" viewBox="0 0 24 24"><path stroke="none" d="M0 0h24v24H0z"/><path d="m6 9 6 6 6-6"/></svg></span><h3 class="text-heading m-0">Technologies We Use</h3></summary><div class="mr-2 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><ul>
<li><strong>Full-stack web-development</strong>, including TypeScript,
React, Sass and Django</li>
<li><strong>Mobile app development</strong> (iOS and Android)</li>
<li><strong>AI/ML model development</strong>, training, testing, and
deployment</li>
<li>Cloud deployments on Amazon Web Services (AWS), Microsoft Azure, and
Google Cloud</li>
<li>Native application development with Qt</li>
<li>Image and signal processing</li>
<li>Especially deep strengths in Python, TypeScript, Rust, C++, C, and
MATLAB</li>
<li>Embedded and real-time systems</li>
<li>Linux, Windows, and macOS</li>
</ul>
<p><img
src="/img/services/Software_Development-87e12cb5b5204f7b9f608af0ec36edc0.png" /></p>
</div></details>

<details class="[&_span.chevron-down-button_svg]:open:rotate-180 bg-white my-5 py-4 px-6 rounded border-solid border border-gray"><summary class="flex flex-row-reverse justify-between items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="chevron-down-button text-center text-xl font-medium ml-2 mt-0"><svg xmlns="http://www.w3.org/2000/svg" width="42" height="42" fill="none" stroke="#2D3F86" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" class="transition-transform relative top-1 w-7 sm:w-8 h-auto" viewBox="0 0 24 24"><path stroke="none" d="M0 0h24v24H0z"/><path d="m6 9 6 6 6-6"/></svg></span><h3 class="text-heading m-0">Cybersecurity</h3></summary><div class="mr-2 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Our cybersecurity team can help you develop secure software that will
keep patients safe and your and your customer’s data secure.</p>
<p>Our Secure Product Development Framework (SPDF) incorporates:</p>
<ul>
<li><strong>Threat modeling</strong></li>
<li><strong>Security Risk Management</strong> (following AAMI TIR
57)</li>
<li>Security by Design</li>
<li><strong>Software Bill of Materials (SBOM)</strong> generation</li>
<li>Cybersecurity Testing</li>
<li>Post-Market Vulnerability Monitoring</li>
</ul>
<p>We can help you navigate navigate buyer’s IT concerns. We also help
with HIPAA. This includes providing copies of the MDS2 form and ensuring
your device makes it easy for your customers to comply with the HIPAA’s
<a
href="https://www.hhs.gov/hipaa/for-professionals/security/index.html">security
rule</a>.</p>
<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Let’s Discuss your Cybersecurity Project</a></div>
</div></details>

<details class="[&_span.chevron-down-button_svg]:open:rotate-180 bg-white my-5 py-4 px-6 rounded border-solid border border-gray"><summary class="flex flex-row-reverse justify-between items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="chevron-down-button text-center text-xl font-medium ml-2 mt-0"><svg xmlns="http://www.w3.org/2000/svg" width="42" height="42" fill="none" stroke="#2D3F86" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" class="transition-transform relative top-1 w-7 sm:w-8 h-auto" viewBox="0 0 24 24"><path stroke="none" d="M0 0h24v24H0z"/><path d="m6 9 6 6 6-6"/></svg></span><h3 class="text-heading m-0">AI/ML-Enabled Devices</h3></summary><div class="mr-2 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Innolitics has deep expertise in image processing, signal processing
and AI/ML model development. Our algorithms have been deployed in
several FDA cleared applications and we can build your algorithm as part
of a new device or to augment an existing device. Our competencies
include:</p>
<ul>
<li>Deep neural network based algorithms for <a
href="https://innolitics.com/articles/visualizing-image-classification/">image
classification</a> and <a
href="https://innolitics.com/articles/medical-image-segmentation-overview/">segmentation</a></li>
<li>Natural language processing and textual data mining</li>
<li>Time series signal processing and anomaly detection</li>
<li>Hybrid traditional and neural network based algorithms</li>
<li>Hand-crafted heuristics based algorithms</li>
<li>Analyzing images and text contained in medical file formats such as
DICOM, NIfTI, and HL7</li>
</ul>
<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Let’s Discuss your AI/ML Project</a></div>
</div></details>

<details class="[&_span.chevron-down-button_svg]:open:rotate-180 bg-white my-5 py-4 px-6 rounded border-solid border border-gray"><summary class="flex flex-row-reverse justify-between items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="chevron-down-button text-center text-xl font-medium ml-2 mt-0"><svg xmlns="http://www.w3.org/2000/svg" width="42" height="42" fill="none" stroke="#2D3F86" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5" class="transition-transform relative top-1 w-7 sm:w-8 h-auto" viewBox="0 0 24 24"><path stroke="none" d="M0 0h24v24H0z"/><path d="m6 9 6 6 6-6"/></svg></span><h3 class="text-heading m-0">Interoperability</h3></summary><div class="mr-2 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Many medical device startups wisely keep their functionality to a
minimum for their first premarket submission. Once you're on the market,
customers often ask you to integrate with EMR Systems, Lab Information
Systems, and PACS.</p>
<p>We are DICOM experts. In fact, over 10,000 engineers and radiologists
visit our <a href="https://dicom.innolitics.com/ciods">DICOM Standard
Browser</a> each month, and it is often the top result in DICOM-related
Google searches.</p>
<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Let’s Discuss your DICOM or HL7 Project</a></div>
</div></details>
<h2 id="faq" class="start-bg text-primary text-center !mt-16 sm:!mt-40 relative -z-10 after:block after:absolute after:-top-8 sm:after:-top-16 after:h-[150vh] after:-z-10 after:w-screen after:left-1/2 after:right-1/2 after:-ml-[50vw] after:-mr-[50vw] after:bg-gradient-to-b after:from-muted_bg after:to-white after:to-90% [&.text-center+p]:text-center">FAQ</h2>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>How much does your typical project cost?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>End-to-end SaMD projects can vary quite a bit depending on several
factors:</p>
<ul>
<li>Whether the core algorithms or models have been proven</li>
<li>The size and complexity of the user interface</li>
<li>The number of platforms that are needed</li>
<li>The risk-classification of the device (higher-risk devices require
more documentation and testing)</li>
<li>The performance or hardware constraints</li>
<li>The number of integrations with external systems</li>
<li>And many other factors.</li>
</ul>
<p>Historically, full end-to-end development of new SaMD projects has
ranged from $250k through multiple millions.</p>
<p>Many of our project-based engagements are much smaller.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>What are your hourly rates?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Please reach out to use and we can provide you a list of our hourly
rates for the following roles:</p>
<ul>
<li>Partner</li>
<li>Director</li>
<li>Senior Regulatory Consultant</li>
<li>Regulatory Consultant</li>
<li>Staff Software Engineer</li>
<li>Senior Software Engineer</li>
<li>Software Engineer</li>
<li>Data Annotation Associate</li>
</ul>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>Do you ever work on a fixed-price basis?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>No. We do not work on a fixed-price basis. For our project-based
engagements and end-to-end engagements we provide detailed cost and
timeline estimates. We refine and periodically update these estimates
throughout the project.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>Can you provide examples of past projects similar to our product?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Yes! Please review <a href="https://innolitics.com/portfolio/">our
case studies</a> for a sampling of our past projects. If you don’t see
anything relevant, please reach out as only a small number of our
projects have case studies.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>How do you handle project management and communication during the development process?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>For staff-augmentation projects we assume you will be managing our
resources along with the rest of your team.</p>
<p>For our project-based and end-to-end engagements we provide project
management support. Here are a few of the highlights:</p>
<ul>
<li>We set up preferred communication channels during kickoff (often
Slack or Microsoft Teams)</li>
<li>We follow an agile process with one- or two-week sprints</li>
<li>During these meetings we demo our work and plan the next sprint</li>
<li>We provide periodic budget and timeline estimate updates</li>
</ul>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>What experience does your team have with FDA regulatory submissions for medical devices?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>We have deep experience with FDA regulatory submissions. We have
three full-time regulatory consultants on our team. Collectively we have
cleared over forty-five 510(k) submissions and several De Novos. Our
engineers are also trained on writing the software and cybersecurity
design history documentation required for FDA submissions.</p>
<p>In short, we are among the most experienced FDA regulatory experts in
the world when it comes to medical device software.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>Does your team do firmware development?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Several engineers on our team have experience with firmware
development, however, we typically are not the best fit for
firmware-heavy projects. We excel on Software in a Medical Device (SiMD)
projects that involve a lot of application-level coding, such as web,
mobile, or desktop UIs, cloud deployments, image processing, etc.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>Can your team help design our user interface?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Yes. Typically we will develop an initial set of UI Mockups in Figma
and will then have a Medical Device UI/UX designers polish and further
refine the slides.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>What if your engineers don’t know a core technology that we use?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Good engineers can usually become proficient using new databases,
frameworks, or even programming languages pretty quickly. Tools like
GitHub Co-Pilot and ChatGPT have made it learning new technologies even
easier.</p>
<p>If this is a major concern, we occasionally will cover the cost for
training engineers on new technologies. </p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>Can your engineers work within our QMS?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Yes! We can work within your QMS or within ours QMS. We are happy to
sign a quality agreement to coordinate quality activities. We can also
train our engineers within your QMS. This often makes sense for Staff
Augmentation engagements.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>Can you help us set up a Quality Management System (QMS)?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Yes. We can get you set up on our Medtech OS platform. This is the
platform we use for our QMS. You can <a
href="https://innolitics.com/services/medtech-os/">read more about
Medtech OS here</a>.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>Can you run our QMS?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>Sorry, although we’re often asked to do this, we do not currently
help companies run their QMS, however, we can provide guidance and
support. We do have several partners whom we can recommend who can help
you run your QMS.</p>
</div></details>
<details class="[&_svg.faq-plus-icon]:open:translate-y-[calc(100%+10px)] [&_svg.faq-plus-icon]:open:opacity-0 [&_svg.faq-minus-icon]:open:translate-y-0 [&_svg.faq-minus-icon]:open:opacity-100 bg-white my-4 py-4 px-3 sm:px-6 rounded border-solid border border-gray"><summary class="flex items-center list-none cursor-pointer [&::-webkit-details-marker]:hidden not-prose"><span class="relative text-center text-xl text-white font-medium mr-4 mt-0 w-[28px] h-[28px] shrink-0 flex justify-center items-center overflow-hidden rounded-full bg-secondary"><svg class="faq-plus-icon absolute transition block w-[12px] h-[12px] fill-inherit" viewBox="0 0 14 14"><path fill-rule="evenodd" clip-rule="evenodd" d="M7 0C7.55228 0 8 0.447715 8 1V6H13C13.5523 6 14 6.44772 14 7C14 7.55228 13.5523 8 13 8H8V13C8 13.5523 7.55228 14 7 14C6.44771 14 6 13.5523 6 13V8H1C0.447715 8 0 7.55228 0 7C0 6.44772 0.447715 6 1 6H6V1C6 0.447715 6.44772 0 7 0Z" fill="currentColor"></path></svg><svg xmlns="http://www.w3.org/2000/svg" class="faq-minus-icon absolute transition block w-[12px] h-auto fill-inherit translate-y-[calc(-100%-10px)] opacity-0" viewBox="0 0 24 24" stroke-width="4" stroke="currentColor" fill="none" stroke-linecap="round" stroke-linejoin="round"><path d="M0 0h24v24H0z" stroke="none"/><path d="M5 12h14"/></svg></span><h3 class="text-heading m-0"><strong>What is your usage of AI in medical device software development?</strong></h3></summary><div class="mr-2 mt-6 [&_ul]:list-image-[url(/img/icons/ul-img.png)]"><p>While we incorporate AI at various points in our delivery process, we
do not treat AI-assisted work any differently from work produced without
it — we take ownership of all deliverables. AI amplifies our existing
value proposition of speed and certainty.<br />
Agentic AI tools like Claude Code and Codex are changing the day-to-day
experience of software engineering. We see this as an opportunity, not a
threat. We are a growing, collaborative team that is actively learning
how to use these tools to produce robust, traceable, high-quality
systems where correctness, safety, and documentation matter.<br />
As an engineer here, you will not only write production code, but also
develop expertise in medical device regulations, quality systems,
verification and validation, and the realities of FDA-facing
software</p>
</div></details>
<div class="not-prose text-center cta-wrapper"><a href="https://innolitics.com/contact/" class="bg-secondary text-white rounded hover:no-underline px-6 py-2 inline-block my-2 hover:transition-shadow hover:duration-150 hover:shadow hover:shadow-secondary/50 text-sm text-center">Have other questions? Let’s talk!</a></div>

## Featured Resources

Here are a few [articles](https://innolitics.com/articles/software/) show-casing our medical-device software expertise: