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.
Formly is the leading platform to manage your MDR compliance. Expert guidance paired with a modern software platform gets you certified fast.
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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 CE marking process for medical devices is centered around meeting the regulatory requirements in the EU region. Companies looking to CE mark their product should typically go through the following steps
-determine their product risk class and regulatory requirements according to EU Medical Device Regulations (MDR) 2017/745,
-establish a Quality Management System to develop your product while creating the required technical documentation,
-undergo a conformity assessment audit from a notified body for your quality management system and technical documentation (unless Class I self-certify),
-finalize their Declaration of Conformity, affix the CE mark, and maintain post-market surveillance requirements.
Formly’s software helps you with all of these steps.
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.
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 CE marked faster and easier, our software can help. Our Document Autopilot generates MDR 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 CE mark 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.