Streamline medical software development and validation for SaMD and SiMD solutions with FDA-compliant support from Innolitics.
Innolitics helps design, develop, document, and validate software for SaMD and SiMD medical devices.
Whether you’re looking for support on a special project or a full-service medical software partner who can get you through the FDA, we can help.
All We Do Is Medical-Device Software
Innolitics has developed software for 70+ medical devices since
2012.
Cybersecurity
Our cybersecurity services include threat modeling, security risk
management, SBOMs, and more.
Medical-Device Standards
Our team has deep knowledge of DICOM, HL7, and other medical-device
standards.
Compliant Software Development
Our medical device software development services comply with ISO 13485
and IEC 62304.
FDA Compliance
We can write all software and cybersecurity documentation for FDA
submissions, with six FDA regulatory consultants on staff.
AI/ML
Our team includes four AI/ML and image-processing experts, including
three PhDs and two MDs.
SaMD and SiMD Expertise
Medtech OS, including its checklists, templates, and tooling, is built
from experience supporting FDA clearance for more than 50 SaMD and SiMD
products.
Every great partnership starts with a conversation. Fill out the form below for a discovery call, and an Innolitics team member will contact you soon.
I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.
Richard Clark
Executive in Residence at Washington University
Innolitics is proud to partner with a diverse array of clients across the medical software industry, from visionary startups to industry-leading Fortune 500 companies. Typical clients include:
Clinician Founders
Venture-Backed Startups
Medical Device Companies
Academic Research Institutions
Our expertise spans a broad range of medical-device software applications, both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products.
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 applications, including:
Digital Diagnostics
Medical Image Viewers
Software for IVDs and LDTs
Mobile Medical Apps
Digital Therapeutics (DTx)
Software Accessories
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:
Radiology
Digital Health
Radiation Oncology
InVitro Diagnostics (IVDs)
Dental
Cardiology
Pre-Clinical
Ear Nose and Throat
Neurology
Gastroenterology and Urology
We engage with our clients in three different ways to support medical device software at every stage of development, through FDA clearance and beyond.
We help you complete software development projects with a defined scope. For example:
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.
We provide experienced medical-device software engineers to augment your in-house team.
Our engineers are trained on the FDA regulations and guidance and can work within your QMS.
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.
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.
We can be your full-service software partner for a new medical product. This engagement model is often appropriate for:
We will work with your team to design, develop, validate, FDA clear, and maintain the software for your new medical-device product.
If you don’t have a regulatory consultant, we can also be your regulatory partner. Read more about our regulatory services here.
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.
Our cybersecurity team can help you develop secure software that will keep patients safe and your and your customer’s data secure.
Our Secure Product Development Framework (SPDF) incorporates:
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 security rule.
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:
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.
We are DICOM experts. In fact, over 10,000 engineers and radiologists visit our DICOM Standard Browser each month, and it is often the top result in DICOM-related Google searches.
Proof, not promises
Explore a few of our many case studies:
Prototype → 510(k) → QMS → FDA audit passed. Multi-year partnership with ongoing development.
Multi-Year Partnership: CBCT Development → FDA Clearance → Maintenance → Support → M&A Support
UI design, Custom C++, Qt, Python development, IEC 62304 and FDA software documentation for a successful 510(k) submission
MATLAB to Python port with performance improvements, documentation, and verification
Our medical software development services have helped SaMD and SiMD solutions get to market ahead of schedule and under budget.
Access our library of resources to learn more about medical device software development and validation.
ArticleRegulatory
This article discusses engineering and regulatory factors to consider when deciding to rewrite or reuse existing prototype code. It should be useful to researchers or companies ...
J. David Giese
ArticleRegulatory
The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article presents Innolitics’...
J. David Giese
ArticleRegulatory
Medical-device software release frequency is a common question, particularly from software engineers familiar with agile development. The answer hinges on two key factors: wheth...
J. David Giese & Jim Luker
End-to-end SaMD projects can vary quite a bit depending on several factors:
Historically, full end-to-end development of new SaMD projects has ranged from $250k through multiple millions.
Many of our project-based engagements are much smaller.
Please reach out to use and we can provide you a list of our hourly rates for the following roles:
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.
Yes! Please review our case studies 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.
For staff-augmentation projects we assume you will be managing our resources along with the rest of your team.
For our project-based and end-to-end engagements we provide project management support. Here are a few of the highlights:
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.
In short, we are among the most experienced FDA regulatory experts in the world when it comes to medical device software.
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.
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.
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.
If this is a major concern, we occasionally will cover the cost for training engineers on new technologies.
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.
Yes. We can get you set up on our Medtech OS platform. This is the platform we use for our QMS. You can read more about Medtech OS here.
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.
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.
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.
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
Whether you need to augment your medical software staff or need an end-to-end software partner, Innolitics can help you clear hurdles and get through the FDA.
