Formly
Automate medical device compliance documentation with AI
Target Audience
- Medical device startups
- Regulatory affairs teams
- Quality assurance managers
- Digital health companies
Hashtags
Overview
Formly simplifies medical device certification by generating audit-ready documents and managing quality systems in minutes. Its AI copilot helps interpret complex regulations while maintaining ISO 13485 and FDA compliance. The platform keeps teams agile with automatic updates for changing standards and seamless document version control.
Key Features
AI Documentation
Generates MDR/FDA-compliant documents with one click
Compliance Alerts
Automatic updates for new regulatory requirements
Multi-Standard Support
Covers ISO 13485, FDA 21 CFR, MDR 2017/745+
Data Ownership
Export all documentation without vendor lock-in
Process Integration
Seamlessly incorporate existing development data
Use Cases
Generate CE Mark documentation
Manage risk assessment workflows
Maintain FDA 21 CFR compliance
Prepare for notified body audits
Conduct post-market surveillance
Pros & Cons
Pros
- Reduces documentation time from days to minutes
- Includes regulatory expert guidance with subscription
- Supports simultaneous EU/US certification
- Maintains compliance through product lifecycle
Cons
- Primarily focused on EU/US markets (limited global coverage)
- Steep learning curve for complete regulatory newcomers
- Requires technical file creation before automation
Frequently Asked Questions
What medical device classes does Formly support?
Supports all classes (I, IIa, IIb, III) for both software and hardware devices in EU/US markets
Can Formly handle post-market compliance?
Yes, includes tools for post-market surveillance and change management
How does Formly stay updated with regulation changes?
Automatically updates documentation templates and sends compliance alerts
Reviews for Formly
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