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Medical device certification

FormlyAI

AI-powered software for medical device certification and compliance in the EU and US.

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Medical device certification Regulatory Compliance EU MDR
More categories (6)
US FDA ISO 13485 AI-powered software Quality management system Technical documentation eQMS
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AI-powered software for medical device certification and compliance in the EU and US
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AI-powered software for medical device certification and compliance in the EU and US

Overview

Formly is an AI-powered software designed to simplify and expedite the medical device certification process, particularly for startups. It offers tools for creating and managing required documentation, expert regulatory guidance, and AI-backed documentation writing to help companies achieve EU and US medical device compliance and get to market quickly and on budget. Formly supports various standards including MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

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Access & connections

Where you can use FormlyAI.

Platforms

Web

Capabilities

What this tool accepts, produces, and is strongest at.

Highlights

  • AI-powered documentation generation
  • Expert regulatory guidance
  • Quality Management System (QMS) creation
  • Technical documentation building
  • Compliance alerts and automatic updates
  • Document approval and revision management (eQMS)

FAQ 9

What is Formly?
Formly is an AI-powered software designed to simplify and expedite the medical device certification process, particularly for startups. It offers tools for creating and managing required documentation, expert regulatory guidance, and AI-backed documentation writing to help companies achieve EU and US medical device compliance and get to market quickly and on budget. Formly supports various standards including MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
How to use Formly?
Use Formly to create and manage medical device documentation, access expert regulatory guidance, and leverage AI to automate documentation writing. The platform guides users through the certification process, from determining product risk class to maintaining post-market surveillance.
What is medical device certification and why is it important for my business?
In the EU, medical device certification is a CE mark, indicating that the product meets EU safety, health, and environmental protection requirements. In the US, it means approval by the FDA, ranging from registration for Class I devices to 510(k) clearance for Class II devices or PMA for Class III devices.
What is the certification process for medical devices?
The certification process involves determining product risk class, establishing a Quality Management System (QMS), creating technical documentation, undergoing an audit (if required), and maintaining post-market requirements.
What are the regulatory requirements for certification and does FormlyAI cover them for my device?
Formly covers all standards required to meet US and EU market requirements, including EU MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62366, and IEC 62304.
I don't know anything about medical device regulations. Is Formly right for me?
Yes! Formly's software is built for everyone, including those unfamiliar with medical device regulations. The Document Autopilot generates MDR and FDA compliant documents, 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.
Can my product be Class I now and then be Class IIA (or Class II) later?
Yes. See more in our blog post on the subject.
How long does it take to get my medical device certification?
This depends on the medical device class. Class I software medical devices can take days to months, Class II (IIa / IIb) medical devices can take months to years, and Class III devices take multiple years.
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