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October 7, 2023

Need Help?

Dr. Oliver Eidel

If you’re lost in regulation, don’t worry! You’re not alone. Sometimes we are lost in regulation, too.

But it’s not hopeless! Check out the sections below to see if one of them describes your situation. Each section lists the options you have. Good luck! :)

Your Situation: You’ve Just Founded a Startup And Have No Idea About Regulation.

You’ve just founded a startup or are close to founding one. You are considering developing medical software and are not sure whether it’s a medical device or not. You also want to learn about how much effort it is to bring a medical device to market, how long it takes and how much it costs.

Don’t worry, that’s a common situation and we’ve answered those questions hundreds times before! Here are your options:

One interesting note here: We’ve seen many founders ask us about our eQMS software, Formwork. Our recommendation is this: You should understand first what sort of compliance documentation you need to create before attempting to automate it. This is a bit like an author looking for text editor software without knowing what to write. Postpone the decision on QMS Software until you have a better understanding - the Wizard is probably the best way to get that.

Still, eQMS software is important - so take a look at Formwork if you’re interested!

Your Situation: You Have Some Documentation, But You’re Not Done Yet.

You’re not starting out from scratch - you already have some documentation which was either drafted by someone from your team or by another consultant. But now, you need help. Either you’re stuck and your progress has come to a halt and you’re looking for help, or you think you’re done and need someone to review it and check whether it’s complete.

Your Situation: You’re Already On The Market, But There Are Problems.

You’re already on the market, but things are not running smoothly. You’d like to make things more efficient because regulatory compliance causes a lot of overhead and you take forever to ship changes to your medical device. Or, you’re short on employees and need some external help to get stuff done.

Your Situation Not Covered Here?

If your situation is not covered by the examples above, send us a message so that we can figure out how to help you and also improve this page in the future!

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

Congratulations! You read this far.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

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!

No QMS on this planet will save you from creating crappy software.