Meri Martinez, Senior Regulatory Affairs Specialist

Meri Martinez

SENIOR REGULATORY AFFAIRS SPECIALIST

Joined: February 13, 2023

Skills

FDA 510(k) De Novo Pre-Subs ISO 14971 ISO 13485 AI/ML-Enabled Devices Device CDS Non-Device CDS Practice of Medicine Exemption

Bio

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.

Hobbies

YouTube, Pickleball, Rare Disease Advocate

Articles by Meri Martinez

Article

System Items vs. Code Implementation: What FDA Actually Expects

Practical tips on how to structure your SaMD architecture for FDA review without mirroring your codebase. Explains what the FDA...

Meri Martinez & Yujan Shrestha

Article

Reference Guide for Testing Expectations for AI/ML-Enabled SaMD

A “quick” reference guide grouping the example 510(k) clearances by their product code/regulation, summarizing required testing...

Meri Martinez

ArticleRegulatory

The Ultimate 510(k) Checklist

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 I...

Meri Martinez & 2 others

ArticleRegulatory

FDA Webinar Notes: Predicate Device Selection and Use of Clinical Data

This article provides an overview of FDA’s webinar regarding a set of guidance documents that were recently released by FDA as ...

Meri Martinez

ArticleCybersecurity

2023 Final FDA Cybersecurity Guidance - Redline

This is a redline between the 2022 Draft cybersecurity guidance and the final 2023 cybersecurity guidance. It should be useful ...

J. David Giese & Meri Martinez