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25 Μαρ 2016 · ISO 13485:2016 for medical device - Overview presentation.Full course at: http://www.iso-13485-2016.com.
In this video you will learn about the structure, principles and clauses of ISO 13485:2016. ISO 13485 is an internationally agreed upon set of standard quali...
14 Απρ 2020 · Download now. The following ISO standards are available in read-only text format: ISO 13485:2016 Medical devices — Quality management systems – Requirements for regulatory purposes. ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk.
23 Σεπ 2021 · The European standardisation bodies CEN and CENELEC published EN ISO 13485:2016+A11:2021 featuring new annexes ZA and ZB that link the requirements of the MDR (Regulation EU 2017/745) and the IVDR (Regulation EU 2017/746), respectively, to specific clauses of the standard.
ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations ensure their medical devices meet both customer and regulatory demands for safety and efficacy.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
After more than 10 years, the updated Quality Management standard with the revision of ISO 13485 for the medical device industry is here. The origins of ISO 13485 standard were closely related to the ISO 9001 standard that provides organizations guidance, context, and requirements for implementing a quality management system.
