Templates

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.

View General Documents templates

ISO 13485 Templates

IEC 62304 Templates

ISO 14971 Templates

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IEC 62366 Templates

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.

View Clinical Evaluation templates

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.

View Performance Evaluation templates

Data Protection (GDPR) Templates

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