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Seperation of the ISO13485/MDR toolkit.

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Guest user Created:   Nov 20, 2020 Last commented:   Nov 23, 2020

Seperation of the ISO13485/MDR toolkit.

I received mdr ISO13485 templates and would like to know how to seperate the folder structure between ISO13485 templates and MDR? I have multiple products and desire one QMS.

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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
Kristina Zvonar Brkić Nov 23, 2020

Templates for the ISO 13485 can and are recommended to be in one folder. Considering MDR, my recommendation is that MDR folders should be organized for one medical device or group (family) of medical devices – it means that each medical device or family of medical devices will have one folder.

A medical device family is a collection of medical devices that have the same or similar intended purpose, have the same risk classification, and have the same design and manufacturing process. Members of the medical device family can differ in the following (for example):

  • in the sizes (e.g. gauzes different sizes, syringes with different volumes, gowns different sizes)
  • strength (e.g. needle force)

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Nov 20, 2020

Nov 23, 2020