Certify your medical device in the EU

Startups use Formly to handle their EU MDR medical device compliance. Our expert regulatory team combined with AI backed documentation writing gets you certified on budget.

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How it works

1. Set up your device

Answer a short questionnaire to help us understand how your devices works, which conditions it is treating and a few other details that tell us what you'll need for certification.

2. Receive your customized roadmap

Based on your input we can automatically provide you a tailored roadmap that outlines every single task you need to complete to get your medical device certified and guidance on how to complete it. It starts with the setup of Quality Management System all the way until the submission to your notified body of choice and registration in EUDAMED.

3. Create documents with step-by-step guidance and AI

Most of the tasks revolve around documenting how your company manages things like risks, post market surveillance, software development, manufacturing, quality assurance and so on. The software guides you through the document creation in a simple step-by-step process and suggests what to write based on how regulatory affairs experts would write them based on their knowledge about your device. It's kind of like having an expert in the room with you.

4. Approve documents with your team

As you have to prove to auditors that everything that you document has been reviewed by at lest two other members of your team, we've included a super simple approval process. Just specify who should approve each document you create, they get a notification and approve with one click. Easy.

5. Submit for approval & certify device

Once every task outlined in the roadmap and all cards are green, you are ready to submit your documentation to an auditor of your choice. Now you have done all the heavy lifting, and it's time to wait for your audit. Once completed you can market your device with CE approval. Congrats! PS, If you are risk class I you can self-declare MDR compliance and CE mark your device. No audit needed.

Focus on go-to market not compliance hell

Formly is the leading platform to manage your MDR compliance. Expert guidance paired with a modern software platform gets you certified fast. 

Expert support

You'll never be let alone. Our experts have certified dozens of devices and are here for you from start to finish.

Automate tedious work

Certification is about documentation. Our software takes care of the mindless work so you can focus on what's important

Quality Management System

Includes a fully compliant QMS setup and eQMS. You can also easily use your own eQMS with our software.

Covers all standards

Interested in the nerdy facts? We support EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 62366 and many more.

Export any time

Your data is yours. No vendor lock in. Export everything whenever you need with the click of a button.

Bring your data

Data integrates seamlessly into our software, making documentation of your processes painless.
Hard facts

Our success in numbers

30+

Devices ceritified

50.000€

Saved on average

800h

per certification saved

The easiest solution on the market. Guaranteed

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Frequently Asked Questions

What is the certification process for medical devices?
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The certification process for medical devices is centered around meeting the regulatory requirements specified by the country you wish to certify your device in. Companies looking to certify their medical device in the EU (CE mark) or in the US (FDA approval / clearance) should typically go through the following steps: 

-determine their product risk class and regulatory requirements according to EU Medical Device Regulations (MDR) 2017/745 or US FDA 21 CFR,

-establish a Quality Management System under ISO 13485 for EU or 21 CFR Part 820 for US FDA,

-create your technical documentation for your device according to the standards relevant for your region,

-undergo an audit your quality management system and technical documentation (unless Class I in EU or 510(k) exempt in US),

-maintain post-market requirements for the device for surveillance and device changes.

Formly’s software helps you with all of these steps.

How long does it take to get my CE mark?
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It depends on your medical device. Class III devices have more extensive regulatory requirements than Class I devices and often take longer to prepare for market entry. Also, notified body audits often take anywhere from 3-12 months to occur. As such, Class I software medical devices can take as little as days to months and Class IIA hardware medical devices can take months to years.

I don't know anything about medical device regulations. Is Formly right for me?
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Yes! Formly’s software is built for everyone. If you are unfamiliar with the medical device regulations or wishing to improve your workflow efficiency to get certified faster and easier, our software can help. Our Document Autopilot generates MDR and FDA compliant documents for you and built in descriptions and video walk-throughs guide you through the rest.

When should I start to work on certification? Can I start too early on this?
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You can’t be too early but you can be late. Once you understand what product you want to build, you can start your certification journey. The regulatory processes and records created while preparing for your certification integrate with product design, development, and testing. By starting your certification procedures early, you integrate quality processes into your workflow and avoid having to repeat steps down the road.

Medical Device Certification Made Easy.