Drafting CE certification - MDR
Hi all!
Just wanted to ask for some guidelines and resources to draft everything required for CE certification documents.
So far, this are the details:
- All our products are WET.
- We're a small team (around 5 people).
- I will be drafting the documents, then taking a revelant course in auditing (the goal is to be able to rely on our internal regulatory team in the long run), perfecting the draft, then send it to our consultant who will review the documents once drafted and will identify the gaps and guide us towards corrections.
- However, unlike ISO 13485 which has loads of material and practical guides and templates out there to draft the documents, I'm very out of depth with the drafting for CE.
Where I’m struggling is finding practical, structured guidance on how to actually draft the documentation.
What are the resources (besides MDR) that provide a guideline of what should be included in each section/document? I would appreciate books that can be used as reference as well. Are the MDCG enough to cover everything, or should they be supplemented with other materials?
The ideal would be something like Juuso's Developing an ISO 13485, but I don't seem to find anything close and the books I've found explain things superficially.
Also, for both CE and ISO 13485, which other ISOs should we take into account(e.g. ISO 14971, IEC 62366, etc)? (I've got a list of a bunch, but it's hard to determine what's required from what's extra and nice to have, it's our first time, it's so much it's overwhelming!)
Thank you so much in advance.