Medical Device Software Development and Validation

We help you complete software development projects with a defined scope. For example:

• Custom Web-Based GUIs
• Medical Imaging Software
• SMART on FHIR apps
• Adding DICOM or HL7 Integrations to existing products
• Independent Software V&V for submissions
• Refactoring Existing Software
• Training New AI/ML Models
• Image Processing Algorithm Development
• Translating Research Code into Compliant Code
• Developing Companion Apps

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:

• Busy Clinician Founders
• SiMD Startups without an in-house Software Team
• Companies Fully Outsourcing Development of a new Software as a Medical Device Product

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.

• Full-stack web-development, including TypeScript, React, Sass and Django
• Mobile app development (iOS and Android)
• AI/ML model development, training, testing, and deployment
• Cloud deployments on Amazon Web Services (AWS), Microsoft Azure, and Google Cloud
• Native application development with Qt
• Image and signal processing
• Especially deep strengths in Python, TypeScript, Rust, C++, C, and MATLAB
• Embedded and real-time systems
• Linux, Windows, and macOS

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:

• Threat modeling
• Security Risk Management (following AAMI TIR 57)
• Security by Design
• Software Bill of Materials (SBOM) generation
• Cybersecurity Testing
• Post-Market Vulnerability Monitoring

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:

• Deep neural network based algorithms for image classification and segmentation
• Natural language processing and textual data mining
• Time series signal processing and anomaly detection
• Hybrid traditional and neural network based algorithms
• Hand-crafted heuristics based algorithms
• Analyzing images and text contained in medical file formats such as DICOM, NIfTI, and HL7

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.

End-to-end SaMD projects can vary quite a bit depending on several factors:

• Whether the core algorithms or models have been proven
• The size and complexity of the user interface
• The number of platforms that are needed
• The risk-classification of the device (higher-risk devices require more documentation and testing)
• The performance or hardware constraints
• The number of integrations with external systems
• And many other 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:

• Partner
• Director
• Senior Regulatory Consultant
• Regulatory Consultant
• Staff Software Engineer
• Senior Software Engineer
• Software Engineer
• Data Annotation Associate

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 set up preferred communication channels during kickoff (often Slack or Microsoft Teams)
• We follow an agile process with one- or two-week sprints
• During these meetings we demo our work and plan the next sprint
• We provide periodic budget and timeline estimate updates

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