12/02/2019
Trying to figure out where to start with documentation for a medical device? We recently published an article on the topic going over the first document to draft: User Requirements.
https://www.meddeviceonline.com/doc/documentation-priority-for-early-stage-medtechs-part-user-specification-0001
Cooper Consulting Service will be releasing additional articles on initial medical device documentation in the coming months.
If you want to know how this fits into the larger process of medical device product development, we also put out an article on the process of going from prototyping units to production units:
https://www.meddeviceonline.com/doc/understanding-prototype-development-phases-for-medical-products-0001
This article lays out considerations and a process for developing user specifications when developing a new medical device. It is the first in a...
