Toolbit.ai
Toolbit.ai
Regulatory ComplianceMedical Device ComplianceQuality Management System

Formly

Automate medical device compliance documentation with AI

Monthly Visits: 3.3K
Freemium
Free Version
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Formly

What is Formly?

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 of Formly

  1. 1

    AI Documentation

    Generates MDR/FDA-compliant documents with one click

  2. 2

    Compliance Alerts

    Automatic updates for new regulatory requirements

  3. 3

    Multi-Standard Support

    Covers ISO 13485, FDA 21 CFR, MDR 2017/745+

  4. 4

    Data Ownership

    Export all documentation without vendor lock-in

  5. 5

    Process Integration

    Seamlessly incorporate existing development data

Formly AI Tool Use Cases

  • 📄
    Generate CE Mark documentation
  • 🛡️
    Manage risk assessment workflows
  • ⚖️
    Maintain FDA 21 CFR compliance
  • 🔍
    Prepare for notified body audits
  • 📈
    Conduct post-market surveillance

FAQs from Formly

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

Pros & Cons of Formly

Pros (4)

  • Reduces documentation time from days to minutes
  • Includes regulatory expert guidance with subscription
  • Supports simultaneous EU/US certification
  • Maintains compliance through product lifecycle

Cons (3)

  • Primarily focused on EU/US markets (limited global coverage)
  • Steep learning curve for complete regulatory newcomers
  • Requires technical file creation before automation

More Info About Formly

Who is using formly?

This tool is best for:

  1. Medical device startups
  2. Regulatory affairs teams
  3. Quality assurance managers
  4. Digital health companies

Formly's Tags

Explore more niche AI tool websites by clicking on a tag* (works only if it has enough tools).

#AIDocumentation #MedicalDeviceCompliance#QualityManagementSystem#FDACertification#MDRCompliance

Website Analytics of Formly

Formly Website Traffic & SEO Analysis:

Recent data shows that Formly has 3.3K monthly visits (-14.3% decrease from the previous month), 43.0% bounce rate, and average 1.81 pages per visit.
Traffic is primarily driven by 6 different sources, with users from 5 countries worldwide, led by United States contributing 48% of total traffic. SEO performance is shown by 5 tracked keywords, with "clincial evaluation of the literature sop" being the top-performing keyword with 170 monthly searches. See below for more info.

Monthly Visits

3.3K

(-14.3%)

Pages per Visit

1.81

Bounce Rate

43.0%

Average Time on Site

45s

Traffic Trend(Apr 2025 - Sep 2025)

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Top Keywords

SEO KeywordVolumeCPC
clincial evaluation of the literature sop
170-
traceability matrix iso 13485 template
90-
formlyai
40-
formly au
30-
udi
60.1K$1.02

Traffic Sources Distribution

Traffic Share by Source

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Source Breakdown Details

SourceTraffic Share
Direct
45%
Search
39%
Social
7%
Referrals
7%
Paid Referrals
1%

Global Traffic Distribution

Traffic Share by Country

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Geographic Breakdown Details of top 5 countries

Country NameTraffic Share
United States48%
Germany29%
Spain15%
United Kingdom7%
India2%
Analytics data is estimated (from third-party analytics providers) and for reference only.

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