![]() Safety and performance of medical devices are the most important in this highly regulated industry this is why quality management systems are a regulatory or legal requirement in many countries. Organizations should be re-certified every three years to maintain their ISO 13485 certification status. Manufacturers who have not addressed ISO 13485 should start assessing their QMS to find out whether there are any gaps to meet the ISO 13485 guidelines and realign processes for compliance. ![]() FDA ISO 13485 QMS standard for medical devices enables controlling processes to ensure that the end product meets the desired quality and safety requirements. This signals an essential step forward for the international standard, which is already used globally. In May 2018, FDA first proposed revising its current Quality System Regulations (QSR) under 21 CFR Part 820 to more precisely align with the international ISO 13485:2016 standard as the basis for its quality system legislation. Without an integrated approach to regulations, implementing best practices to ensure that regulatory processes are followed and adequately documented is still more challenging. As medical device supply chains are rapidly globalizing, regulatory bodies have dealt with how to bridge the gap between domestic and foreign regulations.
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