It enables users to develop their expertise with a medical devices QMS and with regulatory compliance.The new annexes enable manufacturers and notified bodies to conduct a gap analysis to identify where attention is needed to supplement the standard to meet new European requirements.It further harmonizes regulatory requirements between different jurisdictions and thereby decreases the number of unique requirements for individual markets.It can help you demonstrate conformity with regulatory requirements.It can help you implement an effective medical device quality management system that consistently produces safe and effective medical devices.It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.īS EN ISO 13485 was last revised in 2016 and in 2021 was confirmed for a further 5 years.
It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose. It gives regulatory requirements for quality management systems for medical devices. Medical device manufacturers and other organizations in the supply chain for medical devices including authorized representatives, importers and distributors.BS EN ISO 13485:2016+A11:2021 is the 2021 amendment to the standard which comprises new annexes showing the relationship between the clauses of the standard and the requirements of the European medical devices regulations and IVD medical devices regulation. This international standard sets out regulatory requirements for medical device quality management systems.
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