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NAMSA Webinar: MDR 10.4: What Should We Really be Doing to be Prepared?
July 19, 2019 @ 10:30 am - 11:30 am
Join BioOhio member NAMSA for the webinar MDR 10.4: What Should We Really be Doing to be Prepared? on July 19 at 10:30 am.
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-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?
Time will also be allotted for Q&A. Click here to register!