Should we have risk management procedure including FMEA for all product lifecycle?
We bought the toolkit MDR/ISO13485 and have the following question:
If we are a manufacturer (specification holder) and we have contract manufacturer for all our products (so practically we outsource design and development and all manufacturing stages but we only do sales activities for products under our brand name/trademark), should we have a risk management procedure including an FMEA for all the product lifecycle? Or we only make a quality agreement with the manufacturer (OEM) which includes all the requirements and we supervise implementation?
A note all our contract manufacturers are MDR Compliant and ISO 13485 Certified.
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Apr 24, 2023