Quality & Risk Control for Medical Devices

The Medical Device Primer series provides the most efficient means of acquiring the background knowledge necessary to “hit the ground running” as a new engineer, sales/marketing associate, product manager, or supervisor in the medical device industry. Information from leading industry publications, industry insiders, website resources, and textbooks has been streamlined into single, concise, cohesive primers on five different topics. Where space does not allow for complete coverage of a topic, links to the best source available for further information are provided.

The Quality and Risk Control issue covers GMP; quality system regulation; design controls; complaint handling; CAPAs, document control; risk management; and risk analysis tools.