Innolitics LLC

Innolitics LLC specializes in medical device software development and FDA regulatory consulting. Since 2012, the firm has worked on over 70 medical device projects, with their team having achieved FDA clearance for more than 50 Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products. The company focuses exclusively on medical device software, distinguishing itself from generalist software development firms.

The company offers three primary service categories: software development for medical devices, FDA regulatory consulting including 510(k) submissions, and FDA cybersecurity compliance. Their technical team includes four AI/ML and image-processing specialists, including two PhDs, enabling them to handle complex medical imaging and artificial intelligence projects. Innolitics provides both full-service development and targeted regulatory support, with specialized offerings like guaranteed AI/ML FDA clearance programs and fast-track 510(k) services.

The firm has worked with companies ranging from early-stage startups to established healthcare organizations. Their client portfolio spans radiology, orthopedics, dental, neurology, and in vitro diagnostics. Notable achievements include completing FDA submissions in as little as seven weeks and delivering AI-powered diagnostic platforms from concept to clearance within compressed timelines.

Choose Innolitics when you need a partner who understands both the technical complexity of medical device software and the regulatory requirements for FDA clearance. The company's track record of guaranteed timelines and clearance rates makes them particularly valuable when facing submission deadlines or navigating challenging FDA interactions.

Their full-service model works well for companies lacking internal regulatory expertise or documentation, while their guided services suit teams that need strategic direction and quality review. Expect a pragmatic approach that prioritizes efficient paths to clearance over maximalist documentation efforts.

Innolitics works exclusively in medical device software, with particular concentration in radiology and medical imaging applications. The firm's healthcare expertise spans FDA regulatory pathways including 510(k) submissions, Pre-Submissions (Q-Subs), and Breakthrough Device Designations. They specialize in DICOM standards, medical imaging workflows, and AI/ML applications for diagnostic purposes.

Their cybersecurity practice addresses FDA-specific requirements including threat modeling, security risk management, and Software Bill of Materials (SBOM) documentation. The company serves multiple healthcare specialties including radiology, orthopedics, dental imaging, neurology, and in vitro diagnostics, demonstrating breadth within the medical device sector.

The ideal Innolitics client is a medical device company developing software-based or AI-powered diagnostic tools that require FDA clearance. This includes venture-backed startups building their first regulated product, established device manufacturers adding software components, and companies facing urgent FDA submission deadlines. Clients typically need either full-service development and regulatory support or expert guidance to supplement internal teams. Budget-conscious companies seeking predictable costs and timelines will appreciate their fixed-fee guarantee programs.