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Din en iso 13485 2016 pdf11/5/2023 ![]() There are currently 5 out of the 228 planned to save Europe from health dramas. Europe published a first list of harmonized standards to the regulation in July 2021.The CEN CENELEC has been mandated since May 2020 to provide harmonized standards for regulations.The 2018 ISO TR 17223 bridges the gap between ISO 13485:2016 and the requirements of Regulation 2017/745.A harmonized standard consists in an ISO or IEC standard, complemented by Z-annexes that bridge the gap (convergences and deviations) between the standard and the European regulation.The regulation asks that manufacturers to use harmonized standards to achieve conformity.The MDR (European Medical Device Regulation) was published in May 2017, and is applicable since May 2021. It requires manufacturers to implement a QMS. The Regulation (EU) 2017/745 frames medical devices in Europe.It enables the implementation of a quality management system (QMS) in a medical device context, for regulatory purposes. This annex is a necessary ste^for the harmonization process of 13485. It includes Annexes ZA and ZB that link the standard to the requirements of Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro diagnostic medical devices). Requirements for regulatory purposes) is available. ![]() Amendment A11 to ISO 13485 ( Medical devices.
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