Iso 13485 compliance12/1/2022 ![]() ![]() BSI, as one of the leading EU notified bodies and UK approved bodies, can verify medical device manufacturers’ selection of the most efficient conformity assessment routes to achieve CE and UKCA marking. ISO 13485:2016 remains a state-of-the-art document. ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations and UKCA marking medical devices under the UK MDR 2002. ![]() Companies need to become familiar with the ISO 13485 standard and begin preparing now. ISO 13485 is the international quality management standard for medical devices, issued by the International Organization for Standardization (ISO). ISO 13485: an overview of the latest revision. ISO 13485 is the best internationally accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. The latest ISO 13485 standard is more aligned with existing FDA regulations, but that does not mean there won’t be QMS gaps to address as United States medical device manufacturers seek compliance. Compliance with the ISO 13485 standard allows a medical device manufacturer to produce and sell safe and high-quality medical devices for various purposes. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.Īlthough ISO 13485 certification is not mandatory for CE marking medical devices under the European Medical Device Directives (AIMDD, MDD, IVDD), it is harmonized, which allows the presumption of conformity to the Directives. ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ![]()
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