For ISO 13485, IEC 62304, ISO 14971 and IEC 62366
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Download them for free and get your compliance done, no strings attached. Our templates currently cover compliance for ISO 13485, IEC 62304, ISO 14971 and IEC 62366.
General Documents
These include your intended use (super important) and your MDR classification document, among others. These are the most important ones so you should probably get started with those first.
ISO 13485 Templates
The ISO 13485 is the standard for quality management in the medical device industry. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the ISO 13485 so far. Additionally, we publish all our document templates for the ISO 13485 for free, so scroll down and have a look at those! If you fill those out, you have a good chance of already being compliant with the standard, no consultants required :)
IEC 62304 Templates
The IEC 62304 describes how to develop and document software for medical devices. This is an overview over our free templates which we’ve published for the IEC 62304 so far. In other words, if you use these templates, you have a pretty good chance of being compliant with the IEC 62304 :) Enjoy!
ISO 14971 Templates
ISO 14971 is the standard for risk management of medical device software. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the ISO 14971 so far. Additionally, we publish all our document templates for the ISO 14971 for free, so scroll down and have a look at those! If you fill those out, you have a good chance of already being compliant with the standard, no consultants required :)
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IEC 62366 Templates
The IEC 62366 is about usability of medical device software. In practice, it’s mostly about running usability tests with users. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the IEC 62366 so far. Additionally, we publish all our document templates for the IEC 62366 for free, so scroll down and have a look at those! If you fill those out, you have a good chance of already being compliant with the standard, no consultants required :)
Clinical Evaluation Templates
In simple terms, your Clinical Evaluation is a rather lengthy document which looks a lot like a Bachelor’s thesis (yup). Its main goal is to show that your software will be effective and that its risks are acceptable.
Performance Evaluation Templates
The performance evaluation is a requirement for IVD software under the IVDR (formerly the IVDD). It’s somewhat similar to the clinical evaluation for medical devices, but focused less on clinical data and more on (you guessed it) performance.
Data Protection (GDPR) Templates
GDPR compliance is not the main goal of our website, but it’s a building block in becoming compliant anyway.