ISO 13485 PDF Download

You’re probably looking for a free PDF download for the ISO 13485, the standard for quality management for medical devices.

If you’re looking for a short answer, the TLDR is that it’s essentially impossible to find a free PDF for the ISO 13485 online. Believe me, I’ve tried. Anyway, the simplest solution is to use the Estonian website (link to instructions).

You see, I grew up in the golden ages of the internet when BitTorrent and then, later, one-click hosters were a thing. So, suffice to say, I do have some skills when it comes to searching. I attempted to search for the ISO 13485 PDF when, at my first company, we were getting started on our medical device certification. I didn’t manage to find it.

Why a PDF Download Of The ISO 13485 Is Not Freely Available

Why is is not really available? The most likely reasons are:

  • It’s watermarked – the name of the company (yours?) which purchases it gets added to the footer or side of the PDF.
  • The total number of companies purchasing these standards is super low, which further reduces the likelihood of it showing up online.

Anyway, by now you’ve probably noticed that I’m only wasting your time because I created this page for our search engine optimization so that we’d get more visitors like you.

Download the ISO 13485 PDF From The Estonian Website: Not Free, But ~30€ And The Same Content

The final and most pragmatic approach is to purchase the standards on the Estonian website. Here’s a link to my article with a price comparison and instructions on how to get it done.

The standards there usually cost around 30€, so I think that’s fair enough given that the other websites easily charge 100-600€ which is beyond ridiculous. That being said, the whole situation that these sort of standards are not freely available should be rather embarrassing for the EU – and there’s actually an ongoing discussion on whether they might become freely available in the future.

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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