Medical Devices Validation, Regulation, Compliance.Information & training presentation.
The design, manufacture, processing of medical devices, demands an understanding of the various medical device regulatory requirements and international standards, e.g. FDA Process Validation requirements, ISO 13485, ISO 14971, etc.. How are medical devices classified? How do you integrate risk into the validation process? How do you perform a validation gap analysis? How is validation effectively performed during product design? How to validate a medical device containing software? Etc., etc..
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CONTENTS of currently available Medical Device information & training presentation.