Certify your medical device in the EU & US
Trusted by next-gen companies.
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Quality Management System
Create your fully ISO 13485 compliant QMS within minutes. No need to spend thousands on templates and workshops.
Technical Documentation
Effortlessly build audit-proof documentation with our AI copilot. Don’t stress out over wording or interpreting standards and guidance documents.
Change Management
SOUP List
Software Validation
Usability Evaluation
Clinical Evaluation
Risk Management
Post-Market Surveillance
Design controls
Technical File
Software Processes
Scales with you
No matter what your market, team size, your compliance experience or your budget is.
eQMS
Our software comes with batteries included to easily manage document approval and revisions.
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Expert Guidance
Your regulatory strategy, guidance, compliance validation or audit support from our regulatory team that has certified countless devices.
How it works
A crystal clear path to your certification.
Focus on go-to market not compliance hell
Formly is the leading platform to manage your medical device compliance. Expert guidance paired with a modern software platform gets you certified fast.
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Rapid iteration
Stay agile, keep fast release cycles, and don’t get stuck after your device is certified
Automate tedious work
Certification is about documentation. Our software takes care of the mindless work so you can focus on what's important
notifications
Compliance alerts
Automatic updates and reminders for any new requirements. Compliance on cruise control.
Covers all standards
Interested in the nerdy facts? We support MDR 2017/745 and US FDA 21 CFR, along with 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.
Autopilot
Documentation you’ll enjoy making.
Achieve more, write less
AI generated MDR compliant documentation with the push of a button.
Dead simple process
Only a few steps needed to create complex documents that would otherwise take days to complete.
QMS ready, expert approved
We make sure all documents meet the highest regulatory standards.
Roadmap
No more questions where to start.
Absolute clarity
All requirements in plain language with clear steps to success.
Monitor your progress
Focus on what work should happen next. Maintain velocity and make meaningful progress.
Any device class
It doesn’t matter if you are a software only device or hardware or class I, IIa, IIb, or III
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Certify your device in record time
Ready to start the certification process today?
Get started today with our free trial and free expert guidance.
Try it outGet started today with our free trial and free expert guidance.
Frequently Asked Questions
What is medical device certification and why is it important for my business?
In the EU, medical device certification is a CE mark for your product. CE is an abbreviation of "conformité européenne" which equates to European conformity. CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. CE marking is especially important for medical devices which must meet a high regulatory standard before being allowed on the market.
In the US, medical device certification means approval of your product by the US Food and Drug Administration (FDA). This can be as simple as registration of your device in the FDA database for Class I products, to 510(k) clearance for Class II devices, or PMA for Class III devices. In all cases, medical products like medical devices are under regulatory scrutiny of the FDA and need to satisfy the FDA requirements in order to be sold on the US market.
What is the certification process for medical devices?
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.
What are the regulatory requirements for certification and does FormlyAI cover them for my device?
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.
I don't know anything about medical device regulations. Is Formly right for me?
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?
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.
Can my product be Class I now and then be Class IIA (or Class II) later?
How long does it take to get my medical device certification?
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.
