Cooper Consulting Service

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

Documentation Priority For Early Stage Medtechs — Part 1 User Specification This article lays out considerations and a process for developing user specifications when developing a new medical device. It is the first in a...

Cooper Consulting Service had an article published today about "Understanding Prototype Development Phases For Medical Products". The article helps tie together the development goals, time & cost expectations, and design controls needed at each stage of prototyping.

https://www.meddeviceonline.com/doc/understanding-prototype-development-phases-for-medical-products-0001

Understanding Prototype Development Phases For Medical Products Medical device prototypes at each development stage have a utility that needs to be understood to justify the cost and time invested to develop them. ...

Here is a link to our recent blog post about medical device prototyping phases:

Understanding Prototype Development Phases - Cooper Consulting Service Having a common understanding of the functional utility for each stage of prototype development is essential to managing the expectations for everyone involved in a project, from the designers to the executives and the investors. Prototypes at each development stage have a utility that needs to be u...