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MDR 10.4.1: What Should We Really Be Doing To Be Prepared?



Date(s) - July 19, 2019
12:00 AM - 12:00 AM

Access this On-Demand Webinar Here. 

In this webinar, NAMSA’s regulatory and testing experts will discuss the restricted materials compliance sections of the Medical Device Regulation (MDR), specifically Section 10.4.1-Substances. As outlined in this guidance, manufacturers are to reduce risk posed by substances or particles that may be released from a device; however, what does this really mean in practice, and how might sponsors adequately reduce risk?

Provided throughout this webinar will be guidance and answers provided for these common questions:

  • What information can I expect and use from my material vendors?
  • How does ISO 10993 address this and is it simply enough?
  • What types of testing might be necessary, and more importantly, how do I decide if I need to conduct testing?

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