Suggestions for MDR Auditing tools

cscalise

Starting to get Involved
#1
Hello,

I am looking for resources to assist in performing internal audits for MDR. I have taken a course and received some tools, but looking for more resources. There is so much information in the EU MDR that trying to develop a comprehensive and logistically feasible audit plan feels a little overwhelming.

I found the following online:
  • The MDR Tool: a comprehensive excel workbook that seems great but comes with a hefty price $$$, not sure if I want to invest the expense.
  • The Meddev Solutions EU MDR Guidebook: I've reviewed a sample and it seems like it could an asset but holding off purchase until I've done a little more research. I saw in another thread here that gave positive feedback.
Any other suggestions for checklists (not my favorite method, but I like to use in the planning stages to organize my audit path), books, templates, etc... I'm willing to invest if the tools are useful.

Thanks!
 
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shimonv

Trusted Information Resource
#2
I haven't seen a useful tool out there, and I think it's a bit too early to look for one. We, including the NBs EC regulators, are still on the learning curve.
Having said that, perhaps splitting the internal audit to two parts might work for you; one part dealing with the core QMS (ISO 13485) and the other, towards the end of the year, to review MDR specifics. Hopefully towards Q4 we will all be wiser.

Shimon
 
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