Description
NAMSA Summit: Risk-Based Testing Strategies for Medical Devices:
From Material Characterization to Regulatory Compliance (ISO 10993-1:2025 & FDA Perspectives)
In regulatory matters, it is important to balance regulatory strategy with its practical application to achieve effectiveness and efficiency in the manufacturing process. NAMSA is pleased to offer all BMDC members in Tijuana a complimentary presentation on these topics, including breakfast, led by one of our regulatory experts. This session will provide practical insights into navigating regulatory requirements while supporting operational excellence and successful product development.
Agenda:
8:00-8:30am: Welcome, Registration and Buffet
8:35-9:35am : Session 1 – Strategy & Regulatory Framework
• Overview of ISO 10993-1:2025 and FDA expectations
• Risk-based approach to biocompatibility (ISO 14971)
• BEP / BER / TRA and their role in compliance
• Updating legacy documentation (MDD to MDR/FDA)
9:35-9:50am: Buffet break
9:50-10:50am: Session 2 – Practical Testing & Decision-Making
• Test selection based on device risk and materials
• Material characterization, extractables & leachables
• Practical examples and case-based discussion
10:50am-12:00pm: Networking
Event Details:
- Duration: 4 hours (from 8AM to 12PM)
- Cost: free
- Location: Hotel Tijuana Marriott – Blvd. Agua Caliente 11553, 22420 Tijuana, B.C.
Speaker
Chad Reiter, PhD, DABT, NAMSA Toxicologist
Chad Reiter is a Board-Certified (DABT) Toxicologist at NAMSA. With over 7 years of experience in the medical device industry, his previous positions at NAMSA include Medical Research Manager (Study Director) and Senior Scientist. Chad’s expertise includes physiology, cellular biology, device biocompatibility, toxicology, and in vitro and in vivo test methods. He obtained his bachelor’s degree in Biochemistry from North Central College and his PhD in Physiology from Penn State University. Before joining NAMSA, Chad was a post-doctoral fellow at the National Institute of Health (NIH) and a Commissioner’s Fellow with the FDA. While at the FDA, Chad investigated the use of blood substitutes in various therapies. His research investigated oxygen delivery following hemoglobin modifications and the toxicity of interacting with cell-free hemoglobin.
