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 Workshop
You're just starting out and you're not sure where to start? We generally advise you to develop a prototype of your product first before dealing with regulatory work, but there are a few things which you should consider first.
Those are: Which class of medical device will your product likely be? What will be part of the medical device? And what will the exact next steps (including timeline and costs) be towards certification?
Those are the things we discuss in our regulatory strategy workshop. It's geared to put you on the right path before you dive heads-down into product development.
Getting everything done from scratch (QMS & Techdoc)
Your product is mostly done (or you know when it'll be) and you're ready to get started with regulatory work.
We've guided more than 40 companies, mostly startups, through this process! You'll go through our proven Headstart program which includes videos, document reviews with weekly meetings, and regulatory software. This will bring you to market in the most efficient way, typically faster than other consultants.
Have a look at our separate Headstart page for more information.
Regulatory software & automation
You're wondering how regulatory software can help you make everything more efficient and automate the painful parts of regulatory compliance?
Look no further. We've developed Formwork, a super-easy-to-use software which helps you become compliant in the most efficient way possible.
Head over to our Formwork page to have a look.
699€ / month
You've created your documentation already and need someone to review it "like an auditor" before finalizing it?
We can take a look and provide you with advice on what things will most likely be found by auditors and in which areas you can gain efficiencies.
The ISO 13485 requires you to do internal audits of your company regularly: Before your initial QMS audit by your Notified Body, and every year afterwards.
Auditors should be somewhat impartial to your company. That means that, if you're a small startup, you typically get an external person to do you internal audit.
And - surprise - we offer to do just that.
The price includes our preparation and the writing of our audit report afterwards. Typically, it's be two consultants of us perfoming the audit.
Custom regulatory support
Your task is not listed here?
We've probably done similar projects in the past. We've helped writing documentation, provided support in dealing with audit findings, closed CAPAs and even worked as interim regulatory people while companies were recruiting full-time employees.
Talking about recruiting, Oliver has also done regulatory hiring interviews in the past to help companies find suitable regulatory people.
Let us know how we can help! :)
1.760€ / day
Person Responsible for Regulatory Compliance (PRRC)
As a medical device manufacturer under MDR, you need a so-called "person responsible for regulatory compliance" (PRRC). That person needs to fulfil certain qualifications, e.g. at least one year of experience with quality management systems for medical devices.
Many startups don't have such a person internally because, who would have thought, regulatory people typically aren't part of early-stage startups.
The good news is that you can get an external person (that's us) to fill this role - you pay per month, very similar like for your GDPR Data Protection Officer (DPO).
750€ / month
Data Protection Officer (DPO)
If your medical device processes personal health data, that type of data is considered especially sensitive data under the GDPR. That means you need a Data Protection Officer (DPO).
That person needs to be trained in this area - typically, this is fulfilled by attending a 3-5 day training at a notified body or similar institution.
Most startups don't have a suitable person internally. As with the PRRC, the good news here is that you can hire external people to fill this role.
399€ / month
Questions? Your task not listed here?
Reach out and we'll see how we can help :)