BerlinCert, a Notified Body, recently issued their first MDR product certificate. And, guess what, it was a company which created their technical documentation with Formwork! If you were waiting for further proof that Formwork is the fastest way to create your documentation, this is probably it.

Also: We launched Formwork Starter, where you only pay 49€ / month for all (!) Formwork features as long as you don't have any funding yet and your team consists of 3 people or fewer. So.. if you were waiting for Formwork to become more affordable, this is probably it.

I don't have a grand plan behind this pricing scheme. It's mainly that I see early-stage companies choose Jira, and I hate Jira. Formwork is better, and now it's also cheaper. And we're profitable, so we can take these risks. Jira (Atlassian) is not, by the way.

Onwards to the updates :)

Software Detailed Designs!

What a feature. Formwork now also covers IEC 62304 class C software for which you have to document "software detailed design". When creating (or editing) your Techdoc product in Formwork, you can now select it to be class C, and then you get a new section on the left menu to document software detailed design.

Also helpful for FDA submissions, too - those people tend to always want to see detailed design.

Improved Search!

The search has been greatly improved. This is probably a gigantic understatement because the prior implementation was not great. Maybe because I wrote the code. Here's how it looks now, it even covers folders:

Better Folder Navigation & Design!

We've improved the top bar design and folder navigation! It's more tidy and uses up less of your precious screen space. Here's how it looks:

ChatGPT Integration v2

We've added lots of improvements to our feature which generates your QMS drafts with ChatGPT. Take a look at this video to see what improved and whether ChatGPT might save you time:

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Techdoc Batch Export

Exporting your Techdoc records just became more intuitive. In the past, you had to navigate to QMS --> Batch Exports and select "include Techdoc Records". Now, just navigate to Techdoc --> Batch Exports.

As always, you can export all your Formwork data at any time and there's zero lock-in.

Read-only Audit Export

We've started collaborating with Notified Bodies on making submissions even more seamless, and one idea was that things should (best case) be read-only. So now you can export read-only files for your Techdoc submission in Techdoc --> Audit Export.

Trainings: Check Outdated Documents

When editing a training, Formwork now displays a hint if that training refers to documents for which a newer version is available. You can simply click a link to update the training to refer to its newest document versions. Another huge time saver!

.. and lots of small improvements

As always, a gigantic ton of under-the-hood improvements :)

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QMS

• Fixed links in table of contents (in documents and records) not working.
• Download PDFs instead of opening them in a new tab.
• Folders and documents can now be moved by clicking the three-dots icon in the top right corner.
• Clicking "apply from roles" in the training matrix also appropriately marks trainings as n/a if those were not required by relevant roles.

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Techdoc

• Change Requests are now part of the sanity check: You get an error if you still have un-approved change requests related to the current release.
• Fixed a bug due to which probability categories could not be saved in rare circumstances.
• Fixed a bug due to which deleted requirements were sometimes displayed.

As always, thanks for using Formwork!

if you're currently on the free plan and are considering upgrading, check out the Formwork page to learn more, schedule a call or simply reply to this email.

Prices now literally start at 49€, so there's no reason to use Confluence, Jira or any other crappy software which gets in your way of creating your medical device documentation in a few weeks.

Have a nice weekend,
Oliver