Medical Device Manufacturing Process

The Medical Device Manufacturing Process should be ensured for quality for each process beginning from the selection of the raw materials to the production of the finished product ready for sales. The standards for the quality of the medical device manufacturing companies are ISO 13485 and 21 CFR 820. As per the EU MDR the assessment of the quality management system of the medical device company is also a requirement for the CE marking. Hence all the manufacturing processes involved, and their evidences must be recorded.

The critical processes included in the Medical Device Manufacturing, create the parts of the device influencing the performance attributes as well as the safety attributes of the device. Hence these critical manufacturing processes must be identified and validated. Some of the critical manufacturing processes include sterilization, dying, welding, heat treating, Cable and wire harness, plastics injection molding and extrusion etc. The evidences for the validation of the critical manufacturing processes form the part of the technical documentation for CE marking of medical devices.


What are documents related to the critical processes validation to be included in the technical documentation? Is the critical processes validation mandatory for all classes of the medical device?

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