ISO 13485:2016 is a quality management system standard specifically designed for medical device manufacturers. The standard is based on ISO 9001:2015, but it includes additional requirements for the medical device industry. The standard focuses on ensuring the safety and effectiveness of medical devices, as well as compliance with regulatory requirements.
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Yes, but also comply with FDA 21 CFR Part 820 (QSR). Many companies use a harmonized QMS that meets both. Your practical guide should highlight the differences. : You can view detailed previews of the