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ISO 10993-1 2018 UPDATES: WHAT ARE THE RELEVENT CHANGES AND HOW IT IMPACTS THE BIOCOMPATIBILITY SAFETY EVALUATION PROCESS FOR MEDICAL DEVICE MANUFACTURERS - Hosted by NAMSA

Don Pohl (Manager of Biological Safety and Validation, NAMSA)

Location: 209B

Date: Tuesday, February 5

Time: 8:30am - 9:10am

Track: Classroom Seminar

Vault Recording: TBD

Audience Level: All

Since 2009, the emphasis on a risk management process and characterization of materials continues to shift the biological safety paradigm. Put simply, the days of medical product manufacturers simply contracting with a testing laboratory, reviewing and accepting a recommended product evaluation plan is no longer a globally accepted practice.
In today’s world, there is continued interest in how an evaluation is conducted long before any biological tests are performed. And, with the release of ISO 10993-1:2018 in August 2018, there is a continued focus in biological safety planning and implementation processes, as well as the characterization of materials. Once again, medical device manufacturers are being asked to go beyond the simple process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety. This informational session, presented by Don Pohl (Principal Product Development Strategist, NAMSA), will take a look at the major changes introduced within ISO 10993-1:2018, and also discuss how manufacturers can efficaciously prepare for implementation of these new requirements.

RSVP Here:

https://mdmwest.mddionline.com/namsa