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Become compliant in 6 weeks.

Fixed price, clear roadmap.
Even if you have no regulatory knowledge.

MDR Class I, IIa and IIb.

Regulation is complicated. Becoming compliant is hard, especially for startups.

I've seen multiple startups nearly fail due to not solving "the regulatory problem". Why does that happen? Is compliance so hard?

In my experience: No. Startups are motivated to ensure that their products are safe and compliant. And the regulations aren't that complex.

Instead, it's us, it's the regulatory consultants. We're doing a crappy job.

Regulatory Consulting is ineffective and slow.

And Healthcare startups are suffering.

Problem #1

No Roadmap, No Timeline

Becoming compliant should be just like any other well-run project: Plannable. There's a list of required activities which are well-defined. Then, there's a clear plan until when the project will be done.

Unfortunately, that's rarely the case. Projects are ill-managed with people getting stuck in minor details. It's entirely unclear when compliance will be achieved, if at all.

This is dangerous. Startups need a clear timeline. They need to enter the market and get customer feedback. They need a CE label for investors.

Problem #2

Mismatched Incentives

While becoming compliant, you're juggling a bunch of other tasks: Getting investors, hiring employees, writing code. You have to maximise efficiency. That includes regulatory compliance work.

Unfortunately, consultants aren't incentivised to maximise your efficiency. They bill by the hour, so it's in their interest to hold elaborate workshops, schedule long calls and create complex documents.

I've seen this myself: When I get stuff done in a few minutes, I earn less money.

That's not good. Incentives must be aligned. You should only pay for something when it gets done, and your consultant should be rewarded when they get stuff done fast.

Problem #3

No Cost Control

What happens when your consultant bills by the hour and you have no roadmap? You lose cost control. I have seen startups spend anywhere between 10.000€ and 150.000€ for the same outcome.

If you have unlimited money, that may be fine, but in the real world, it's better to have a plan for how much money you're going to spend.

Regulatory Consulting is just like any other project: It can be estimated and should be fixed-price.

We can do so much better.

Introducing Headstart.

A predictable, fixed-price program for startups becoming compliant.

Available for selected startups.

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Access is on a first-come, first-served basis.

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