Background:
I founded MedDev QE Solutions in 2025, after 30+ years in medical device and combination-product quality. Nineteen of those years were at Johnson & Johnson, across Ethicon, Cordis, Codman Neurovascular, Acclarent and DePuy Synthes. I then held director roles at Siemens Healthcare Diagnostics, Bard Access Systems (BD) and Owlet. Most recently I was Director, Medical Device & Combination Product QA at Pfizer.

My specialty is risk management, and the design and development work and post-market data it depends on. I've written the corporate standard, run the risk management system for a five-company group, and remediated files one at a time. That mix is what lets me set a standard a team can actually follow at volume.

How I work:
I'm a mechanical engineer by training, and I work hands-on. Clients get the person they spoke to. I don't name clients, and I don't discuss one client's regulatory matters with another.

Products I've worked on:

• Vascular access, neurovascular and cardiovascular devices, including drug-eluting stents

• ENT, minimally invasive devices

• Combination products: prefilled syringes, auto-injectors, pen injectors and inhalers

• In vitro diagnostics

• Electrical medical equipment (IEC 60601)

• SaMD, including design review and approval

Credentials:

• B.S. Mechanical Engineering, Massachusetts Institute of Technology

• ISO 13485:2016 Lead Auditor, BSI

• Listed committee member on six published AAMI standards: ANSI/AAMI/ISO 14971:2019, AAMI/ISO TIR 24971:2020, AAMI/ISO TIR 20416:2020, AAMI CR34971:2022, AAMI TIR34971:2023 and AAMI TIR45:2023

• U.S. expert on the ISO/TC 210 Spanish Translation Task Force for ISO 14971 and ISO/TR 24971, since 2020

• Bilingual in English and Spanish, including standards work in Spanish

Contact: hfelix@meddevqes.com | (877) 250-5022 | LinkedIn