Iso 13485 and FDA Qsar template

[Mga_MD]

Hi all
We are a small start up and some members have some brief experience in quality assurance (qa)

We would like to start implementing a qms system as per iso13485 and FDA CRF 21 820

I would like to ask you if anyone could recommend any templates available online to start implementing de qms. Ideally templates should be valid for EU (iso 13485) and FDA and ideally MDSAP as well. I see many websiteals offering templates but would be happy to hear about reccomendayions so that we can choose the best templates possible

Thanks!

 

[Nichole F]

There is a website called "Open Regulatory" that offers some templates. Be sure to review them though. Also, for FDA part 820, it is incorporating ISO 13485:2016 by reference so be sure any templates you choose to use take this into consideration. The rule was finalized earlier this year with a two year transition period allowed. Enforcement of this is scheduled to begin February 2026.

Using the MDSAP Audit Approach document is extremely helpful to understand exactly what auditors are looking for for evidence of conformity/compliance. It doesn't include EU MDR/IVDR though. Your best bet for that is to take an ISO 13485:2016 based procedure then integrate any additional MDR/IVDR requirements. The document is available online. I usually access it via FDA's website but I'm sure there are other places to find it.