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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:
Both risk management and biocompatibility start with device design but continue through production and post-production information collection and evaluation. People who will particularly benefit from this presentation include:
Dan O’Leary, Ombu Enterprises LLC. For more than 30 years, Mr. O’Leary has been practicing or training others in quality, operations and program management in regulated industries. He has developed a systems approach to operations management that reduces arcane regulatory concepts into everyday language. A Six Sigma Black Belt, he is an ASQ-certified biomedical auditor and is certified by APICS in resource management.
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