ISO 13485 Amendment, Templates, User Manuals

Dr. Oliver Eidel
Updated June 11, 2024

Quite a few regulatory things have happened recently! Before we wrap up the year, let’s take a quick look. We’ll be off starting next week, so happy holidays and see you in January! ūüôā

Regulatory Updates

ISO 13485: 2021 Amendment Released
It contains new annexes ZA and ZB which map the 13485 requirements to the MDR and IVDR. You can purchase it from the¬†friendly Estonian site¬†for 37.33‚ā¨ incl. tax (choose PDF, English and Multi-User Licence for 2 users).

New Regulation on Electronic User Manuals
Finally, there’s some certainty on the whole electronic user manual fiasco situation. There’s a new¬†EU regulation¬†and Sven posted a great¬†update to our¬†article¬†on how you should handle the user manual situation for your medical software.

Website and Template Updates

Article: How to Get Your UDI
In my opinion, the whole UDI implementation is very confusing and my gut feeling is that smart people would have come up with something better. Now we have a weird three-tier system of numbers in which you need to pay random private companies for UDI numbers. Anyway, Sören tried to entangle this mess and wrote a step-by-step article on how you can get your UDI.

New Templates: Software Validation
Sven created and uploaded our templates on 13485 Software Validation which I had promised to various people a thousand years ago:
SOP Software Validation, Software Validation Form
As Software Validation seems to be a huge pain point for most companies, I’ll write an article on this soon (yeah, soon!).

New Template: ISO 13485 Mapping Document
One of our most repeated suggestions is that you should create a mapping document in which you “link” the standard requirements to your documentation. That way you can show auditors where you implemented which part of the standard. We now have a mapping document for the ISO 13485:
ISO 13485 Mapping Document

New Template: MDR Requirements Checklist
One of the most important documents in your MDR Techdoc submission in which you show how you complied with all the MDR requirements. Sven went to great lengths to build a really nice checklist template for that:
Checklist: MDR General Safety and Performance Requirements

New Templates: Purchasing & Suppliers
Lots of new stuff regarding the purchasing and supplier requirements of the 13485:
SOP Purchasing, Supplier Checklist, List of Qualified Suppliers

Various Template Updates
We’ve updated various templates after doing an internal audit (we actually have a 13485 QMS internally). Unfortunately, our website doesn’t have any way to show you what we updated (sad dog face) but I hope to have a solution for that in the future.
Updated templates: SOP CAPA, CAPA List, SOP Document and Record Control, SOP Integrated Software Development, SOP Feedback Management, SOP Human Resources, SOP Internal Audit, SOP Incident Reporting

LinkedIn Discussion on Classification Chaos
My¬†LinkedIn post¬†on the recent¬†MDR Classification Fiasco article¬†sparked a bit of a discussion. The most relevant point for me was that another guidance document,¬†MDCG 2019-11, provides a bit more information on software classification¬† – but not much. To make matters more confusing, I’ve heard from competent authorities actually classify software as class I which would have been class IIa or higher based on the guidance documents. I mean, that’s really nice of them and I’m really happy for those companies who “got away” with class I. But we still don’t have any certainty of how MDR class I software really looks like.

On a slighty different note: You want to get your medical software certified under MDR but don’t know where to start? No worries! That’s why we built the Wizard. It’s a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We’ve built Formwork, and it even has a free version!

If you’re looking for human help, did you know that we also provide consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish¬†in their medical device compliance.

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