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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
5
2323 ratings
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
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