Besides the Formwork AI features, the free open regulatory templates are one of your biggest levers when it comes to getting your medical device compliance documentation done in as little time as possible.

Did you know that OpenRegulatory started out as a small website, mainly offering free templates for EU MDR medical device compliance? In any case, a lot of things have happened in the meantime, and In the meantime, we've built an eQMS software called Formwork, whose manual you're looking at right now.

And in the meantime, we've integrated all the free OpenRegulatory templates in Formwork. This means you no longer have to clunkily download them as Word files and re-upload them in your QMS software - Instead, using our free templates is a matter of a few clicks!

Note that if you used our fancy Formwork AI feature for generating your QMS completely from scratch, you probably don't have to do any of these steps below, because Formwork will already have copied over all our free templates into your folder structure and customized them with the company data which you provided in the AI assistant. So, this manual entry mainly focuses on copying over individual templates if you at some stage have a need for those.

Finding the free OpenRegulatory Templates

In the top menu, select QMS, and then in the left menu, select OpenRegulatory Templates. You will be greeted with the folder structure of the templates:

The templates are currently grouped into three sections:

Data privacy documentation: Templates which you need for EU GDPR compliance.
Quality management system: Templates for you to become compliant with the ISO 13485, which is the standard for quality management in medical devices.
Technical documentation: Templates for you to fulfill the standards on technical documentation for medical devices specifically the IEC 62304, IEC 62366 and ISO 14971. Note that, strictly speaking, using the Products section in Formwork, which we'll talk about later, already fulfills quite a few of these requirements.

Using (and Copying) a Template

Using a template, i.e. copying it to your folder structure is very easy. Simply click on a template, here's how it looks:

As you can see in the top right corner, you can choose to use this template either for a new document or for a new record. It depends on your company's individual QMS setup which choice is more appropriate. E.g., as a rule of thumb, SOPs are documents. For more information check out our separate post on differences between documents and records.

After selecting to either use it as a template for a new document or for a new record, you can subsequently choose which folder in your Formwork QMS folder structure you would like to copy it into.

A Quick Note on Product Records

Note also that you essentially have three targets where to store documents and records:

Your QMS Documents folder in the menu on the left side: This is where you store your company-wide documents for your quality management system.
Your QMS records folder in the menu on the left side too: Likewise, this is where you store your company-wide records for your quality management system.
Product records: This section is not displayed in the screenshot above because it's only visible once you click on Products in the top menu. There, you store records which are related to an individual product, i.e. a medical device of your company. So, for example, your intended use would be stored as a record within one of your products.

So, when choosing to use an OpenRegulatory template for a new record, you can subsequently choose to move it to one of your products as a product record. This keeps things tidy and ensures that you actually store product related documentation alongside your product.