Ah yes, you’ve finally gathered the courage to sign up for an eQMS software and deal with this whole messy affair of regulatory compliance for your medical device company. Good job!
Now you’d like to get started. Cool! There’s a minor complication to this though: In my five years of being in this weird industry, I’ve come to learn that people signing up for an eQMS software often have no clue about regulatory compliance. But that’s fine! So I’ll walk you through Formwork and, at the same time, explain some basics of medical device compliance. Let’s get started.
After you’ve logged into your Formwork account, you’re greeted with a dashboard which might look just like mine, albeit yours might be slightly more empty and won’t contain the “Admin” section:
Now the question is what you’d like to do next. I’ll simplify things greatly for you by giving you three choices:
- You want to set up your company’s Quality Management System (QMS). This is about creating lots of documents describing the processes at your company. You have to do this exactly once for your company, regardless of how many products (medical devices) you want to bring to market.
If you’d like to do that, click on “QMS” in the top bar.
Click here to learn about managing your QMS in Formwork. - You want to start documenting your product. This boils down to listing all features of your software (or hardware), how you tested it and which risks it entails for patients. You have to do this for each of your products.
If you’d like to do that, click on “Products” in the top bar.
Click here to learn more about documenting your product in Formwork. - You have absolutely no clue what any of these things mean and would like to learn more about regulation. Luckily, we’ve got you covered (this wasn’t always the case, nervous chuckle). Click on “Courses” in the top bar to check out our video courses, many of them are free!
Click here to learn about how courses work.
Okay, not quite three choices, here are a few more, based on frequently asked questions by people like you:
- Formwork Pricing: What are the differences, when to upgrade, how to downgrade, minimum commitment and cancellations.
