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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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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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.
This all 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. Your development time for creating and testing your product will always depend on your company and product type. Generally, Class I software medical devices can take as little as days to months. Class II (IIa / IIb) medical devices can take months to years, and Class III devices take multiple years.
When it comes to reviewing your certification submission, in the EU, notified body audits often take anywhere from 3-18 months to complete for Class IIA, IIB and III products. In the US under the FDA, the review for 510(k)s take 30-90 days while Premarket Approval (PMA) can take up to 180 days. Typically, 510(k)s are for Class II products and PMAs are for Class III products.
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.
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.
