A fundamental requirement for any controlled process is to have the documentation associated with the process to be “controlled.” What do we mean by controlled? Document control implies that one can distinguish one revision of a document from another revision. It also implies that a particular revision is retrievable and unblemished – that is, five...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.