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Episode 195 | Don Pohl and Sheri Krajewski at NAMSA | Tips to Successfully Navigate Biocompatibility Testing of Medical Devices

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Manage episode 442903766 series 2788129
Content provided by Project Medtech. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Project Medtech or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

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

  continue reading

256 episodes

Artwork
iconShare
 
Manage episode 442903766 series 2788129
Content provided by Project Medtech. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Project Medtech or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

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

  continue reading

256 episodes

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