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  • Oscar Garcia

FDA's Biocompatibility Assessment Resource Center

I found this FDA's resource page very interesting and straight to the point. In addition to following these recommendations, I think it is important to carefully choose the Lab you are going to work with. In my experience working with different Labs, I’ve found that some of them are very helpful assisting you when you are facing challenges. Remember, when things go well, it is easy, but when things go bad, you need the right resources to help you find adequate solutions in order to overcome any obstacles and achieve compliance.


https://www.fda.gov/medical-devices/premarket-submissions/biocompatibility-assessment-resource-center?utm_medium=email&utm_source=govdelivery

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Responsibilities Actively execute quality assurance in design development, including but not limited to: Support design control deliverables. Author verification and validation protocols and reports.