Why Validate a Medical Device product or process?...Medical Device Validation is gathering and analyzing data to confirm that a product or process will consistently perform as expected. Process validation is performed to confirm that a process will consistently operate as designed. Product validation will confirm that the product can repeatedly perform as designed. When products and processes are effectively validated, there will be a high level of confidence in the ongoing quality, reliability, safety and efficacy of the outputs of a process, i.e. the final products.
Unexpected quality, reliability, safety or efficacy outcomes can result in process shutdowns, product recalls, regulatory sanctions, litigation, etc.. Validation seeks to minimize the potential for process or product non-conformance to design and development intent.
Medical Device Process Validation >>>
FDA GMP QSR General Requirements >>>
Process HAZOP Analysis >>>
Device History Record >>>
FDA Regulation of Combination Products >>>
Process Validation. Product Validation >>>
EU Medical Device Regulation MDR 2017 745 >>>