Seperation of the ISO13485/MDR toolkit.

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)