Medical Device Software Development & Regulatory Services

We help Medtech companies create and clear Software as a Medical Device (SaMD). Additionally, we can develop your regulatory strategy, build your software (including AI/ML and cybersecurity), draft your design documents, and submit your FDA 510(k).

Our Services

End-to-End Development

We can help new Software as a Medical Device (SaMD) products get onto the market quickly and efficiently. Our team can work with you to identify the best regulatory pathway to market, design and develop the software, and make the premarket submission. We also provide ongoing maintenance and consulting services once your device is on the market.

510(k) Documentation

We can complete your 510(k) software documentation in 3 months, guaranteed. If you're working on, or have nearly finished, the development of a medical device but need help with the software and cybersecurity documentation for a 510(k) submission, we can help.

Regulatory Strategy

Our expert team specializes in guiding companies through the intricate process of creating and obtaining FDA clearance for medical devices, ensuring a smooth, compliant journey from conception to market. We provide personalized support at every step, making the complex FDA approval process straightforward and manageable for healthcare innovators.

Additional Solutions

From staff augmentation to algorithm and AI consulting, including DICOM conference statements, cybersecurity, and technology consulting, our team is dedicated to tackling your challenges and providing tailored solutions for your business needs.

Why Innolitics? We Speak Both Languages.

Our team of software engineers and regulatory consultants has been helping medical device companies get onto the market since 2012. We operate at the intersection of software engineering and regulatory guidance.

We work with:

  • Established device manufacturers looking to rapidly break into the SaMD or AI/ML space
  • Enterprises looking for end-to-end SaMD development
  • Startups with an engineering team looking for regulatory documentation help
  • Clinicians and researchers looking for a team to help commercialize their research or idea
  • Manufacturers on the market in the E.U., Australia, or other jurisdictions who are looking to submit in the U.S.

Trusted by emerging startups to category-leading healthcare companies.

Don't take our word for it.

Innolitics' team epitomized proficiency, professionalism, and precision. Their expertise extends beyond FDA regulations, encompassing intricate facets of DICOM, radiology workflows, and adept software engineering. Venturing into this without their support would have potentially stretched our timeline to 9 months or more. Earning the FDA clearance (K231385), for us, is more than just an accomplishment; it's a monumental milestone.
Amr Abodraiaa

Amr Abodraiaa

CEO of Rology

I needed a software development partner to write the software, train the AI, and get FDA clearance (K202229). An investor once told me that it would take me $5 million and 5 years to get to where we are now. Innolitics got me here 3 years ahead of schedule and $4 million dollars under budget.
Dr. Andrew Smith, MD PhD

Dr. Andrew Smith, MD PhD

Co-Founder at AI Metrics

We needed a team that would get it done right the first time and independently. As a physician, I was delighted to work with another physician engineer on the team that was able to implement complex clinical workflows with very little input from me or my team. Innolitics delivered ahead of schedule and exceeded expectations.
Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT

Dr. Mark Rosenberg, DO, MBA, FACEP, FAAHPM, FACHT

Co-Founder and Chairman of Retrieve Medical

Our Clients Include

Let's Talk

Every great partnership starts with a conversation. Fill out the form below for a 30-minute discovery call, and a Innolitics team member will contact you soon. Additionally, you can book a time directly on our calendar here.