Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.

ISO 13485 is an internationally recognized quality standard that outlines the quality management system requirements for companies involved in the design, development, and production of medical devices. The standard is based on ISO 9001 with additional focus on regulatory requirements specific to the medical device industry.

Most service providers to the medical device industry understand that the primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. What isn’t always well understood is what they need to do to meet the requirements of ISO 13485—or even why they should try.

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