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

Fast 510(k)

You have a nearly finished product but no documentation, and need to submit a 510(k) ASAP.

AI/ML Development

You need help developing a new AI/ML-enabled medical device from scratch or an existing prototype.

DIY 510(k) Accelerator

You are preparing your own 510(k) and are looking for a real example to guide you.

Software Development

You need a software-development partner for a new or existing medical-device product.

FDA AI Request Response

FDA identified major cybersecurity, software, or AI/ML deficiencies that you need rapid, experienced help resolving.

FDA Cybersecurity Remediation Solution

You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter.

Guided 510(k)

You need guidance, training, templates, and document review support for a 510(k) submission.

Medtech OS

Free Notion powered eQMS, ALM, RIM, and FDA approved templates.

Regulatory Consulting

You need to determine the best path to the US market or have other custom regulatory 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.

During a presubmission meeting, the FDA acknowledged that Innolitics were "extremely advanced" in their understanding of the regulations. The FDA essentially concurred with all of Innolitics' advice, demonstrating a deep understanding of the regulations, even in the face of ambiguous topics such as CADe vs non-CADe. They expertly, and politely, navigated the FDA call with our best interests in mind while fostering a collaborative exchange with the agency.
Ilya Pyatnitskiy, MD

Ilya Pyatnitskiy, MD

Cofounder of AUMI AI

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

Innolitics's engineers seamlessly integrate with our existing team. They’ve consistently produced high quality work while helping us solve technical problems in the medical imaging space. In particular, they spearheaded development of a large module that extends our existing product suite. This module has since been cleared be the FDA (K153014) and is live at hospitals around the world. Their work on the module involved software development, researching various image processing algorithms, analysis of these algorithms against real-world data, and writing detailed technical documentation of the system that justified its approach to the FDA.
Nathan Childress, PhD, DABR

Nathan Childress, PhD, DABR

Associated VP at Varian Medical Systems

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

Our Clients Include

Our Partners Include

Let's Talk

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