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Content of the medical device file

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Guest user Created:   Apr 21, 2018 Last commented:   Apr 21, 2018

Content of the medical device file

Setting up the medical device file under the new 13485 have added ISO certs and Manufacturers Instructions is there anything specific I should be adding to it.
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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.

Expert
Strahinja Stojanovic Apr 21, 2018

Answer:

The medical device file should contain the following information:
- General description of the medical device, intended purpose and instructions for use (I think you've covered that)
- specification for the product
- specifications or procedures for manufacturing, packaging, storage, handling and distribution;
- procedures for monitoring and measuring;
- procedure for installation, if appropriate; and
- procedure for servicing, if appropriate.

For more information, see: How to meet ISO 13485:2016 requirements for medical device files https://advisera.com/13485academy/blog/2017/06/28/how-to-meet-iso-13485-requirements-for-medical-device-files/
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Apr 21, 2018

Apr 21, 2018

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