Here's a quick reminder on how the first screen of Formwork looks like:
Welcome!
In the prior Quick Start section, we used AI to generate our QMS, which is your company wide documentation, which you only have to do once for your entire company. That's the "AI-Generate QMS" button on the left side here.
Now, let's look at how you can create your technical documentation, which is the documentation you have to do once for each of your products (or medical devices). That's the right section here with the "Create Product" button. When you click it, you'll see this screen:
New Product
If you were worried that you actually would have to do some work here, I've got great news for you: Formwork also has an AI integration to create your product documentation for you. Simply check the checkbox "Start with AI-generated content" (it's already checked by default).
Above that you have to enter your product name, a description of your product, the type of your product and the IEC 62304 software safety classification. A few quick notes on those:
The Description should be the intended use of your medical device or a shorter version or more human readable version of it - our AI will use this to start generating your documentation for you.
Type can be software, software and hardware or hardware - this can't be changed later as it pre-configures the type of data which you will enter and maintain for this product. So choose wisely.
IEC 62304 Software Safety Classification can be A, B or C. Likewise, this also configures what sort of data you will be entering into Formwork and it also can't be changed later, so choose wisely here, too. From our consulting experience, it's extremely unlikely that software is Class A nowadays because apparently auditors have, with their subjective assessments, all agreed that Class A software is just very rare. Also from experience, probably 95% of software is class B. Class C is exceedingly rare and reserved for only extremely high-risk software. For example, if you plan to develop software for cardiac pacemakers. If in doubt, choose Class B.
And that's it! Once you've entered everything, hit Save. And then Formwork will go ahead and generate your product documentation for you.
Similarly, as for the QMS documentation, this used to take months and cost thousands or even tens of thousand euros with consultants. And now you can get it done in just a few minutes!
There is however still work cut out for you as you will have to review all the AI-generated content and go through all the Formwork sections to understand them properly. The medical device compliance regulations are still rather clunky, which means you do have to explain all of this to an auditor in person when they will review your documentation.
So in the next few sections, you will understand how to use each small feature of Formwork so that you fully understand how it works and can maintain it going forward.
