Building great machine learning systems?

Let's get them certified. Without much hassle.

medical device manufactorer developing an ML/AI-based SaMDmedical device manufactorer developing an ML/AI-based SaMD

What are you working on?

If you're visiting this site, chances are you're working in one of the two areas mentioned here. Select applicable one and continue scrolling down.

This is what you have to do

Because of the EU Medical Device Regulation, your product needs a CE mark before you can place it on the EU market. This requires you to set up a quality management system and to draw up technical documentation for your product.

Medical Device Regulation (MDR) certificiation of machine learning / artificial intelligence based software

Our solution for you

We get to know each other in a kickoff meeting. You get our templates, tailor-made for AI-based products, and fill them out. We assist you, and review them together. You end up with a quality management system and technical documentation, ready for audit. The total price tag is 50k EUR.

consulting process diagram:  Start off with ML/AI-specific templates, fill them out, and get them reviewed for regulatory conformity according to the EU MDR or AI Act. At the end, you're well equipped to receive a CE mark.

About us

We combine first-principles thinking with regulatory veterancy to build solutions that best fit your needs, and help you navigate the regulatory jungle in all phases of your project.

Prof. Dr. Oliver Haase, Co-Founder and Regulatory Expert

Prof. Dr. Oliver Haase

Co-founder

I have an academic background in software engineering and profound regulatory experience for medical devices and AI/ML technologies. I have co-founded ValidateML because our customers need proven regulatory strategies, no overblown documentation monsters.

Kai Haase, Co-Founder and Machine Learning Expert

Kai Haase

Co-founder

I have an M.Sc. in computer science with a specialization in artificial intelligence. I have co-founded ValidateML because our customers build cutting edge solutions and need regulatory support by people who deeply understand the technology they use.

Contact us

If you think that or wonder if we can help you, please get in touch with us. Fill out the form, and once we are in touch, we'll schedule a personal web call. Free of charge, of course.

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