ISO 10993-1: Understanding the Use and Value of Biocompatibility Safety Evaluation and Risk Assessment Standards for Medical Devices

Release Date
April 11, 2018 11:00 AM-12:00 PM EST

View the recorded webinar here*

Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan.

In today’s world, however, the simplicity of the above process is increasingly questioned given the requirements of ISO 10993-1: Biological evaluation of medical devices; Part 1 – Evaluation and testing within a risk management process. This is in part due to the requirement set forth within ISO 10993-1 that indicates medical device manufacturers go beyond the minimalistic process of identifying a set list of biocompatibility tests when evaluating a device’s biological safety.

This webinar, presented by Don Pohl (Principal Product Development Specialist, NAMSA), will take a look at the basic requirements of ISO 10993-1 and how device organizations can effectively identify processes to meet regulatory standard for multiple regulatory bodies.

Questions to be addressed include:

View the recorded webinar here*

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests.

At any time, you can submit a request to withdraw your consent for the use of information provided by you by emailing communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com

NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.