SENIOR REGULATORY AFFAIRS SPECIALIST
Joined: February 13, 2023
I have led or supported 15+ FDA 510(k) clearances — primary correspondent on 8 — including a Special 510(k) cleared in 29 days and AI/ML-enabled SaMD for CT, MRI, and dental radiography. Since joining Innolitics in February 2023, I have project-managed 13 client engagements and personally led six clearances through FDA review: BodyCheck's CT Cardiomegaly (K232613), Radical Imaging's FlexView Diagnostic DICOM viewer (K233226), Smile Dx's dental CADe (K242437), GECHO contrast-echocardiography analysis software (K250120), Neosoma's brain-metastasis segmentation software (K252922), and AdvaHealth Solutions' AdvaView radiological image-processing software (K262449). I advise on complex strategies with little established precedent including generative AI (LLM and VLM) devices, Device versus Non-Device CDS determinations, non-device classifications, and premarket submission exemptions; for small and large, domestic and foreign, multidisciplinary teams; have drafted De Novo and Breakthrough Device submissions. I co-authored The Ultimate 510(k) Checklist on the Innolitics blog and hold a B.S. in Biomedical Engineering from UT San Antonio.
I am a regulatory affairs professional with 5+ years guiding FDA submissions and regulatory strategy for medical devices, the last 3+ focused on AI/ML-enabled Software as a Medical Device (SaMD). Consulting has kept me on a steady stream of first-of-their-kind technologies, where the regulatory path usually isn't written yet and every project teaches me something new. What matters most to me is the person on the other end of the submission, and getting the details right because someone's care depends on it.
Mom, Rare Disease Advocate, Pickleball
Article
Practical tips on how to structure your SaMD architecture for FDA review without mirroring your codebase. Explains what the FDA means by “system/software items,” how to use mult...
Meri Martinez & Yujan Shrestha
Article
A “quick” reference guide grouping the example 510(k) clearances by their product code/regulation, summarizing required testing and the rationale behind it.
Meri Martinez
ArticleRegulatory
This checklist is meant to assist in the review of a 510(k) submission. It is a version of the checklist we use internally at Innolitics when we’re reviewing 510(k) submissions ...
Meri Martinez & 2 others
ArticleRegulatory
This article provides an overview of FDA’s webinar regarding a set of guidance documents that were recently released by FDA as a continued effort to modernize the 510(k) process...
Meri Martinez
ArticleCybersecurity
This is a redline between the 2022 Draft cybersecurity guidance and the final 2023 cybersecurity guidance. It should be useful to medical-device regulatory professionals who wan...
J. David Giese & Meri Martinez
