We’re Launching Free Consulting

Dr. Oliver Eidel
Updated April 17, 2024

OpenRegulatory started out as an experiment of me brain-dumping my regulatory knowledge to a website. I was like, “well, I’m leaving this field, but it would be great if my knowledge gets written down somewhere so that other people could use it and experience less regulatory pain. Then, I can finally develop software again and do cool stuff”.

The first part actually worked out really well! Our templates are pretty much complete, and startups can set up, like, 95% of their documentation with them, for free! I think that’s really, really cool.

I recently was contacted by a medical software startup from Australia which only consisted of one person! Literally, one dude in his garage, writing software and using our templates. I thought that was amazing – not the fact that he was in a garage, but the fact that we had enabled someone to get close to entering the market who would, under normal circumstances, not have the financial resources to pay for expensive consulting.

But would it be safe to enable one-person startups to enter the market? Before answering that, let me ask you this: Would it be safe to leave the system as it is, in which most medical software is developed by large enterprises and is inherently user-unfriendly, bug-ridden and ineffective? (If you don’t believe me, visit a hospital.) Is it safe to uphold the high financial barrier of entry for medical software so that software can only be developed for large “business cases”, and it’s not worthwhile to develop software for rare diseases, leaving them untreated?

I think that’s not good. By lowering the barrier of entry for everyone, we can try to make the Healthcare software market, well, more of a market – and not an oligopoly. The best software truly should succeed, measured by patient satisfaction, effectiveness and, of course, safety.

Talking about lowering the barrier of entry – what comes next?

After making our templates available for free, we’ve moved on to launching our fixed-price offers for consulting. Because – if I can hire a plumber to fix my sink and that person can quote me a fixed-price offer, why would a regulatory consultant not be able to do the same thing?

But sometimes startups might not need a full-blown fixed-price offer. They just might have a few questions. They might not have decided yet on whether to enter the Healthcare industry at all. In that sense, they don’t even need a consultant, because they aren’t even a customer. Can we lower the barrier for them, too, and answer their questions? I think we can.

That’s why we’re launching our free consulting today. It’s simple: Join us on Google Meet every two weeks for an hour, and ask all your regulatory questions, for free! You’ll meet some other friendly startups, too.

And, who knows, after a couple hundred free consulting sessions, maybe all those startups can help each other. That would be great, because then we finally don’t have to do consulting any more and can move on to more productive endeavours, like developing Formwork.

See you at the next free consulting call?

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 consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.

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