It's summer in Germany, which means that many people are not working because they're on their well-deserved holiday. The holiday season also gives everyone the unique perspective of how it might feel working on EUDAMED, where no progress seems to have been made over the last few months / years. I wonder whether those people are on some sort of perma-holiday. Just kidding.. I suppose you know what I mean.

Regardless, we've been busy shipping lots of big and small features to Formwork. There's some truly cool stuff in there. Check them out below and have a great day!

Oliver

Generate Your Risk Management With AI

When you start your technical documentation, you're usually faced with a blank slate. Where do you start? This is especially painful for risk management, where you could, in theory, analyze and document hundreds of risks.

All of that goes away with our new AI-based risk management feature in Formwork. The idea is that, once you create a new product, Formwork scaffolds out a suitable risk matrix and risk table for your device (you enter an intended use first).

That's awesome because you no longer start from a blank slate! And it's easier to edit an already-created risk table vs. creating one from scratch :)

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Save Hours By Generating Your Training Quizzes In Seconds, With AI

When creating QMS trainings for your team, you also have to come up with multiple-choice quiz questions and answers. Personally, I think this is quite painful, and even if you do enjoy it (??), it easily takes you at least 30 minutes per training.

Now, Formwork automates this for you with AI. When you create a new training and link it to some of your SOPs, you can ask Formwork to read those SOPs and write the quiz questions for you.

Check it out here:

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Big Improvements

So many big improvements that I had to make a bullet-point list:

• You can now manage multiple companies within Formwork - useful if you're working as a regulatory consultant. Once people of other companies add you as a team member with your Formwork email address, you can switch to their company by clicking on "Switch companies" in the top right corner.
• You can now manage your tasks in Formwork! Navigate to the "Tasks" section in the top menu bar to get started.
• You can now upload Word (docx) and PDF files, and Formwork will automatically convert them to editable "Formwork" documents for you (Markdown). This is super useful when migrating from other (expensive) eQMS providers.
• You can upload documents and records as ZIP files now, too - also useful when migrating from other providers.
• You can now download a self-contained HTML export of your technical documentation in addition to our "old" audit export spreadsheets. The HTML version looks exactly like Formwork in your browser, except that it's downloaded locally to your computer. It's pretty awesome. Navigate to Products --> Audit Export to get started. Part of our collaboration with BerlinCert, a notified body here in Berlin, on improving file formats for audit submissions.
• You can now use AI to edit your documents and records! Click on the three dots in the top right corner and select "Edit with AI". You can now chat with the AI and ask it to make changes for you. Here's a video.
• We made some pretty huge improvements to the trainings view - it's more tidy now and gives you an even better overview over your company's training situation!
• When creating a new product, Formwork uses AI to automatically create user needs and user tests. Saves you some time!

.. and lots of small improvements

General

• You can now login with Google!
• Fixed: Some users occasionally got got logged out of Formwork automatically, this is no longer the case.

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QMS

• You can batch-upload QMS documents and records! E.g. for documents, navigate to QMS --> Documents --> + New --> Upload Documents.
• You can now view which documents and records reference to a specific document.
• CAPAs can now be archived.
• You can finally add your company logo to batch exports! Navigate to settings to get started. Only available on QMS + Techdoc.
• Show a warning when multiple people attempt to edit the same document / record at the same time.
• Show the activity log for CAPAs to see who changed what when.
• You can now filter change requests by status.
• Fixed: Don't show CAPA deadline if the deadline is a description, not a date.
• Fixed: Exclude archived documents / records from being shown when creating a new link to a document / record.
• Fixed: Merging and splitting table cells in the text editor.
• Fixed: When copying a record, use the original creation date for the copied record.

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Techdoc

• Test runs have a progress bar.
• The description of risk table entries is now displayed in the table overview.
• Change requests can now have attachments.
• Fixed: Sometimes, attachments to change requests were not saved.

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And that's it for today. As always, thanks for using Formwork!

Formwork comes in three flavors: Free, 99€ / month and 499€ / month. If you're still on the free tier, consider upgrading as it'll make your medical device compliance (and by extension, your life) so much better!

And if you're on 99€ / month, consider upgrading - for 499€ / month, you get unlimited (!) user seats. No sane company would offer an eQMS like this one. But we do!

Have a great day :)
Oliver