In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the globe, common mistakes and so much more.

Don Pohl LinkedIn

Sheri Krajewski LinkedIn

NAMSA LinkedIn

NAMSA Website

Duane Mancini LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech Website

Mittal Consulting

Rook Quality Systems

Kymanox