Our Services

While we're committed to providing as much free information and templates as possible to make the regulatory space more transparent and accessible to all, we also offer consulting services to pay our salaries and keep OpenRegulatory sustainable.

That's great because that enables us to stay profitable and not require any external funding. This allows us to stray true to our goal of providing first-class support for startups.

Regulatory Strategy Bootcamp

You're not sure how to move forward with your regulatory situation? Let's get together for two hours and discuss your options. We'll talk about your medical device classification and how you can go to market as efficiently as possible.
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Get Everything Done From Scratch (QMS + Techdoc)

While we do share a lot of stuff for free on our website, we also offer to guide you through the process of getting your medical device certified.

We've worked with more than 100 companies, mostly startups, and have successfully passed multiple audits.

That enabled us to develop a proven system which enables startups (like yours) to enter the market in an efficient and predictable way. It's a combination of giving you access to our videos, doing project management and helping you automate your regulatory work with our software.
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Custom Document Review

You've drafted your own documents but would like us to review them before you submit them to your auditors?

No problem. Based on our experience after passing multiple audits, we can take a look at your documents and provide you with feedback on what auditors would likely think of your submission. We'll also help you optimize parts where you can save time in the future.
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Internal Audit

This is a requirement of the ISO 13485 - you need an internal audit, so why not choose us?
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750€ / month

Person Responsible For Regulatory Compliance (PRRC)

The MDR requires you to have a so-called PRRC. It's likely that you don't have a qualified person in your startup because e.g. the person needs more than one year of regulatory experience. So why not outsource this to us, at least for the first year?
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400€ / month

Data Protection Officer (DPO)

You need a data protection officer for GDPR compliance. We also have some in-house dudes who are pretty good at this.
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