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Biocompatibility for Medical Devices
Translating government gobbledygook into English is no small task. And the FDA isn’t the only regulator to worry about. Misinterpret a few words of the EU regs and see how much trouble you’ll land in.
FDAnews has enlisted the aid of a top expert in regulation demystification, Dan O’Leary, as your translator. In just 90 minutes, Dan will help make sense of complex concepts and opaque verbiage that are the rules you must follow, including:
- Understanding the risk management process in ISO 14971:2007 and the EU variant in EN ISO 14971:2012
- Learning how biocompatibility fits into the risk management process
- Understanding how ISO/TR 15499:2016 provides additional and vital information for a comprehensive program
- Seeing how the Essential Requirements from the MDD relate to biocompatibility
- Learning how the harmonized standards help implement essential requirements
- Untangling the biocompatibility expectations of the EU’s new Medical Device Regulation, MDR
- Learning the role of the FDA–CDRH guidance document on biocompatibility
- And much more!
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