FormlyAI
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Formly is a platform for managing EU and US medical device compliance. With AI-backed documentation and expert regulatory guidance, Formly allows startups to navigate the certification process efficiently and get their products to market swiftly.
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#medical device certification
#compliance solution
#ISO 13485
#regulatory compliance
#AI documentation
#FDA compliance
#MDR 2017/745
#technical documentation
#change management
#startup support
#market access
#documentation automation
#regulatory standards
#medtech startups
#EU regulations
#healthcare compliance
#device classification
#compliance alerts
#documentation simplification
#go-to-market strategy
...
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Formly is a platform for managing EU and US medical device compliance. With AI-backed documentation and expert regulatory guidance, Formly allows startups to navigate the certification process efficiently and get their products to market swiftly.
AI Forms
AI Flashcard Maker
Script To Video AI Generator
AI Excel Formula Generator
#medical device certification
#compliance solution
#ISO 13485
#regulatory compliance
#AI documentation
#FDA compliance
#MDR 2017/745
#technical documentation
#change management
#startup support
#market access
#documentation automation
#regulatory standards
#medtech startups
#EU regulations
#healthcare compliance
#device classification
#compliance alerts
#documentation simplification
#go-to-market strategy
...
Featured
What is FormlyAI?
Formly provides a comprehensive solution for startups to achieve medical device certification compliance in the EU and US markets. By leveraging AI technology and a team of experienced regulatory experts, the platform simplifies the documentation process required for ISO 13485 compliance, technical documentation, and change management. Formly ensures that companies can scale according to their needs and stay updated with compliance alerts, automating tedious documentation tasks. Suitable for various device classes, it accelerates the go-to-market process, ensuring that all regulatory standards including MDR 2017/745 and US FDA 21 CFR are met.
Who will use FormlyAI?
- Startups
- SMEs in Medical Device Sector
- Regulatory Compliance Teams
How to use the FormlyAI?
- Step1: Sign up for an account on Formly’s website.
- Step2: Use the MDR Classification Tool to determine the classification of your device.
- Step3: Initialize your Quality Management System using the platform’s templates.
- Step4: Generate technical documentation with the help of the AI copilot.
- Step5: Follow guidance from the regulatory team to ensure all compliance standards are met.
- Step6: Use the platform to manage document approvals and revisions.
- Step7: Conduct necessary audits and submit documentation for certification.
- Step8: Monitor progress and compliance status regularly through Formly’s dashboard.
Platform
- web
FormlyAI's Core Features & Benefits
The Core Features
- ISO 13485 compliant QMS
- AI-driven documentation
- Change Management
- Compliance alerts
- Export capability
- Data integration
The Benefits
- Reduces time to market
- Ensures compliance with regulatory standards
- Automates tedious documentation tasks
- Provides expert regulatory guidance
- Scales with company needs
FormlyAI's Main Use Cases & Applications
- Startups needing MDR or FDA certification
- Companies producing Class I, II, or III medical devices
- Businesses requiring a streamlined process for regulatory compliance
FormlyAI's Pros & Cons
The Pros
Combines AI efficiency with human regulatory expertise for comprehensive compliance management.
Supports a wide range of certification standards and medical device types.
Provides a clear and complete certification roadmap tailored to complex products.
Enables scaling across multiple devices and international markets.
Offers predictable and transparent pricing tailored to client needs.
Automates compliance processes reducing time and resource drain.
The Cons
No open-source availability limits customization or community contributions.
Lacks public presence of mobile or app store platforms.
May require organizational buy-in to integrate with existing workflows.
Detailed info about the extent of AI capabilities is limited on the main site.
FormlyAI's Pricing
| Has free plan | No |
|---|---|
| Free trial details | |
| Pricing model | |
| Is credit card required | No |
| Paid from | |
| Has lifetime plan | No |
| Billing frequency |
FAQs of FormlyAI
FormlyAI Company Information
- FormlyAI Inc.
Analytic of FormlyAI
Visit Over Time
Monthly Visits
3.1k
Avg Visit Duration
00:00:06
Page Per Visit
1.76
Bounce Rate
38.38%
Oct 2025 - Dec 2025 All Traffic
Geography
Top 3 Regions
United States
51.38%
Germany
25.93%
India
22.68%
Oct 2025 - Dec 2025 Worldwide Desktop Only
Traffic Sources
Search
45.76%
Direct
38.01%
Referrals
7.29%
Social
7.14%
Paid Referrals
1.51%
Mail
0.11%
Oct 2025 - Dec 2025 Desktop Only
Top Keywords
| Keyword | Traffic | Cost Per Click |
|---|---|---|
| udi | 87.5k | $ 0.89 |
| severity | 21.7k | $ 1.27 |
| formly | 2.7k | $ 5.07 |
| supplier corrective action request | 840 | $ 3.52 |
| mdr/ivdr | 680 | $ -- |
FormlyAI Reviews
5/5
FormlyAI's Main Competitors and alternatives?
- Greenlight Guru
- Qualio
- MasterControl
- ZenQMS
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