Managing Your QMS In Formwork
When clicking on "QMS" in the top bar, you are greeted with this friendly "My Activity" screen:

But first things first. On the left side, you see the QMS menu. Here are what those sections are about. Click on the link of each section below to learn more - if some things don't have links yet, that means I'm working on them or procrastinating. Here they are:
- My Activity: We just talked about that. Duh.
- QMS Overview: Formwork helps you create a fancy overview table over all your QMS documents which you can show auditors. This will make them very happy.
- Consulting: You probably don't see this in your account. This only appears in the very unlikely case that you're a regulatory consultant and want to collaborate with your clients in Formwork.
- Documents: This is where your QMS documents are stored. Click on it to open up the folder structure. Learn more about documents in Formwork.
- Records: This is where your QMS records are stored. Yep, click on it to open up the folder structure. Learn more about records in Formwork.
- OpenRegulatory Templates: A very awesome section. This is where you can access our completely free templates for your medical device compliance - they cover everything for your QMS and technical documentation for EU MDR medical devices! Same templates as on our website, but way more convenient because you can do easy copy-pasting.
- CAPAs: Manage your corrective and preventive actions (CAPAs). If you don't know what that means, just skip ahead.
- Trainings: Manage your employee trainings. If you think that sounds dumb, then.. hm, don't get into quality management.
- Reviewer Roles: Manage who reviews your documents and records in your team. Learn more about Reviewer roles in Formwork.
- Batch Exports: Export your entire QMS with just one click!
On a different note: Do you need any help with your EU MDR efforts?
We've worked with 100+ companies and helped them certify their devices in weeks, not months. Talk to us now – first calls are free! Check out our services and prices here.
Or, if you don't like talking to humans, check out our Wizard. It's a foolproof, step-by-step video course for getting your compliance done yourself.
And if you're looking for the best QMS software for lean, founder-led companies, check out Formwork. It automates your compliance, and there's even a free version for you to try out!
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Dr. Oliver Eidel
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!