Speaking

I speak on risk management, design and development, and FDA enforcement for medical device and combination-product audiences. Recent and past sessions are below.

Recent

When FDA Enforces ISO 13485

KeyPedia, Warning Letter Wednesday webinar | 21 October 2026. What FDA has cited since the QMSR took effect, in warning letters and Form 483s, and what it means for risk management files. Replay, slides and recap 

Past sessions

Challenges of Executing Risk Management for Combo Products in a Global Supply Chain

MedTech Intelligence, Supply Chain Intelligence Summit | November 2023 | Washington, DC. I also joined panels at the same event on the impact of AI and ML on the QMS, advanced manufacturing, and supply chain challenges. Then: Director, Medical Device & Combination Product QA, Pfizer.

Pfizer Uses Positive Disruption to Manage Product Design Across the Lifecycle

Axendia, Straight from the Source webinar | April 2021 | Featured guest with Daniel R. Matlis. Then: Director, Pfizer. Event page 

Technology's Role in Overcoming a Disrupted Life Sciences Reality

Axendia webinar panel | May 2020. Then: Director, Pfizer. Event brief 

The Executive View on Change Management

Axendia six-part video panel, with Fresenius Medical Care | February 2017. Then: Director of Design Quality Assurance, Bard Access Systems. Videos 

Interested in a session for your team, conference or webinar series? Email hfelix@meddevqes.com