Meri Martinez, Regulatory Affairs Project Manager

Meri Martinez

REGULATORY AFFAIRS PROJECT MANAGER

Joined: February 13, 2023

Skills

FDA Regulatory 510(k) ISO 14971 ISO 13485

Bio

I'm a biomedical engineer and regulatory professional. My journey began in a medical device startup, where I got to wear many hats. I decided to keep my favorite hat on, regulatory affairs, and my career has grown into that of a regulatory professional. Additionally, I'm passionate about guiding and mentoring young students interested in the field of biomedical engineering through my social media platform “The BME Life”.

Hobbies

YouTube, music, real estate, baking, and my two dalmatians.

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 tes...

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