Medical Device Family
Dear 13485Academy, we develop a software as a medical device in Class 1. We are about to develop a new device which has many many similarities with our existing medical device. It uses the same basic structure, design, etc.. However, the characteristics of the users are different, as well as the intended purpose (only slightly, but still). Are we allowed to only have one Technical Documentation for both our products?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
According to both the MDD and MDR, you have a case of medical devices group or family. You can have one Technical documentation for the group of the medical devices with a description of a complete list of the various configurations/variants.
To see how to structure the Technical file according to MDR, see this Technical file template: https://advisera.com/13485academy/documentation/technical-file-template/
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Apr 07, 2020