Startups use Formly to handle their EU MDR medical device compliance. Click "Start Free" below to access our software and cover every QMS process you need for MDR, completely free of charge.
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Formly is the leading platform to manage your MDR compliance. Expert guidance paired with a modern software platform gets you certified fast.
We know we have the back office covered with Formly. They are hands on and make our MDR compliance easy. You get a team who provides guidance on best practices in the medical device compliance world, and you spend a fraction of the time you would on this work otherwise.
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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.
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.
Formly covers all standards that are required to be met by your medical device in order to be on the US and/or EU market.
Medical devices in the EU must comply with the EU Medical Device Regulations 2017/745, also known as MDR, first and foremost. Most manufacturers also use other international standards to ensure they meet all aspects of MDR. Some of these include ISO 13485, ISO 14971, IEC 62366, IEC 62304, and more depending on what type of medical device you have.
In the USA, medical devices must comply with FDA's 21 CFR requirements. The US recognizes many of the same international standards as the EU which makes preparing your medical device for certification in both markets simultaneously a good idea. Formly can ensure you'll be compliant in both.
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.
