The Formwork Manual
Quite a few of articles below are still in progress - you'll notice this if they aren't clickable yet. Please bear with us while we fill in the blanks!
If you have absolutely no clue about eQMS software and Formwork, check out the Getting Started article :) for all other topics, take a look below.
First Steps
- Getting started
- Purchasing: Prices and when to upgrade | Purchasing with the startup discount (799€ --> 499€)
Quality Management System (QMS)
- Overview
- Managing QMS items: Documents | Records | CAPAs | Trainings
- Saving time: OpenRegulatory templates
- Reviewing items: Reviewer roles
- Very cool stuff: QMS overview
- Finished and ready for your audit? Batch export
Technical Documentation (Techdoc)
- Overview
- Software / hardware documentation: Software requirements / design inputs | Software tests | Software test runs
- Risk analysis: Risk matrix | Risk table | Failure modes | Hazards | Hazardous situations | Harms | Risk controls
- Usability engineering: User tests | User test runs
- Very cool stuff: Sanity check | AI drafting | Requirements overview | Risk overview
- Finished and ready for your audit? Reviewing techdoc items | Audit export | Batch export
- Product settings, versioning, changes: Product settings | Releases & versioning | Change requests
Courses
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!