Our Services & Prices
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.
Consulting Packages
Flex
Don't want to commit yet? Just take our pay-as-you-go pricing for custom regulatory support.
Workshop
Get together with one of our consultants for two hours, solve your medical device classification and plan your roadmap to certification.
Do It Yourself
Get your certification done yourself with our proven Wizard video course and QMS software. Get two workshops and a document review to make sure you're on the right track
All Inclusive
We'll help you with everything from start to finish. You'll draft your documents, but we'll hold your hand along the way and make sure you'll succeed.
Price
250€ / hr
400€
One-time, fixed price
9.999€
One-time, fixed price
60.000€
One-time, fixed price
Formwork (QMS Software) included
Purchase for 499€ / month
Purchase for 499€ / month
6 months (~3k€ value)
499€ / month afterwards
499€ / month afterwards
12 months (~6k€ value)
499€ / month afterwards
499€ / month afterwards
Wizard (video course) included
Purchase for 2.999€
Purchase for 2.999€
Included (3k€ value)
Included (3k€ value)
Step-by-step Project Plan
Included
(Step-by-step todo lists for getting your device certified)
(Step-by-step todo lists for getting your device certified)
Calls
Unlimited Calls
Pay by the hour
1 Call (Workshop)
2 hours included
2 Calls (Workshops)
4 hours included - before and after you've drafted your documents
Unlimited Calls
Talk to us any time, e.g. once per week
Email Questions
Unlimited Emails
Pay by the hour
1 Email
Collect your questions after your workshop
5 Emails
Send us your questions while you're drafting your documentation
Unlimited Emails
Send us your questions any time
Document Reviews
Unlimited Reviews
Pay by the hour
No Reviews
Show us your documents in the workshop call
2 Reviews
We'll review your documents once when you've finished drafting them
Unlimited Reviews
Ping us any time when we should review your documents
Other Packages
250€ (30 minutes)
Call with Oliver
I'm the founder of OpenRegulatory and the main author of mosts articles here.
While I've handed off a lot of the day-to-day consulting business to my colleagues (check out the free consultation above and the workshop below!), I'm still available to do some consulting if you'd like to talk to me personally.
The most popular things people ask me are how to build software in an agile way while still achieving regulatory compliance, and how to get your regulatory documentation done in the fastest way possible (weeks, not months).
I've worked with 100+ medical device companies as a consultant and led multiple teams of software developers as an engineer, so I've done this a few times already :)
This is a paid call - 250€ for 30 minutes. So please come prepared to make the most of it!
You'll receive an invoice after the call. If I wasn't able to answer your questions, it's free!
Book a paid call with Oliver →While I've handed off a lot of the day-to-day consulting business to my colleagues (check out the free consultation above and the workshop below!), I'm still available to do some consulting if you'd like to talk to me personally.
The most popular things people ask me are how to build software in an agile way while still achieving regulatory compliance, and how to get your regulatory documentation done in the fastest way possible (weeks, not months).
I've worked with 100+ medical device companies as a consultant and led multiple teams of software developers as an engineer, so I've done this a few times already :)
This is a paid call - 250€ for 30 minutes. So please come prepared to make the most of it!
You'll receive an invoice after the call. If I wasn't able to answer your questions, it's free!
Custom
Custom Regulatory Services
Besides helping you certify your device from scratch, we also offer custom regulatory services. Most commonly, we offer to review documentation you've created before you found us. We can also do internal audits.
And if you're still looking for an external Person Responsible for Regulatory Compliance (PRRC) or Data Protection Officer (DPO), we can provide those, too.
Just reach out!
Contact us →And if you're still looking for an external Person Responsible for Regulatory Compliance (PRRC) or Data Protection Officer (DPO), we can provide those, too.
Just reach out!