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Medical device file structure

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Guest user Created:   Jun 25, 2019 Last commented:   Jun 25, 2019

Medical device file structure

I was looking for the Medical device file structure, which is needed for ISO 13485 and CE. Can you help me with some template for that?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 25, 2019

Answer:
There is no template for Medical device file because its content is defined by the Medical Devices Directive 93/42 / EEC (https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF The Directive states which documents are required. Medical device file template is quite hard to do because there is extremely a lot of different things that are considered medical devices: from spoons for giving antibiotics through a variety of software, infusion tube, gauze and covers for surgery to artificial hearts.

Medical device files includes descriptions of design records, manufacturing processes, product specifications, device usage guides, quality measurement criteria, levels of compliance with regulatory bodies and quality standards, and, if required, servicing and installation records and their guidelines. For more detailes how to prepare medical device file you can find i n following link: https://advisera.com/13485academy/blog/2017/06/28/how-to-meet-iso-13485-requirements-for-medical-device-files/

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Jun 25, 2019

Jun 25, 2019