opensamd/templates

Templates for ISO 13485, IEC 62304, ISO 14971 and IEC 62366 compliance.

OpenRegulatory Templates

Templates for ISO 13485, IEC 62304, ISO 14971 and ISO 62366 compliance.

These are markdown files. If you prefer to download them as .docx, .pdf, and .html files, head over to our website at openregulatory.com/templates.

Rationale

Regulatory compliance is an opaque field, riddled with suboptimal consultants, expensive audits and scarce information.

We (OpenRegulatory) are trying to change that. We started publishing all our templates for free on our website which was a huge success! People all over the world suddenly had the resources to create regulatory documentation in their garages without paying expensive consultants.

Now, we're moving those templates to this public GitHub repository to improve collaboration. Let's see how it works out! :)

Contributing

Contributions are always welcome!

Goal and Thoughts on Contributions

Corrections of typos and general housekeeping is always much appreciated!

Adding new content (like new sentences or sections in templates) is also great. But keep in mind: The goal of our templates is to be as minimalistic as possible. They should enable startups to pass audits, but not to set up the most detailed QMS on this planet. So if your contribution will increase the likelihood of fulfilling regulatory requirements and/or passing audits, that's great!

Accordingly, the best possible contribution would be making changes to the templates after having gone through an audit with them. That would enable everyone else to look at them and say "wow, those actually passed an audit". That would be really cool.

How do you contribute?

Create a pull request and select me (@olieidel) as reviewer.