Formly

Medical Device Certification Made Easy – Solutions Overview

Medical Device Certification Made Easy offers a complete platform for startups and established companies to achieve EU (MDR) and US (FDA) medical device certification efficiently. By combining expert regulatory guidance with AI-assisted documentation generation, Formly helps teams go to market faster while maintaining compliance across multiple jurisdictions. The solution emphasizes speed, affordability, and scalable workflow support, suitable for devices across software, hardware, and mixed-class classifications.

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What this tool does

• Provides end-to-end support for certifying medical devices in the EU (MDR) and US (FDA) markets.
• Combines expert regulatory guidance with AI-powered documentation writing to accelerate the certification process.
• Generates MDR- and FDA-compliant technical documentation and facilitates the creation of a compliant Quality Management System (QMS).
• Supports rapid iteration and scalable workflows to accommodate a wide range of device classes (I, IIa, IIb, III).
• Includes a robust library of templates, checklists, and case studies to guide users through regulatory requirements.
• Offers a free trial with expert guidance to help teams get started quickly.

How it works

1. Define your device scope and regulatory target (EU MDR, US FDA).
2. Build or import your Quality Management System (QMS) documentation using Formly’s framework.
3. Use AI copilots to generate MDR/FDA-compliant technical documentation and post-market activities.
4. Leverage expert regulatory guidance to validate the documentation and plan the certification path.
5. Track progress with automated compliance alerts, version control, and export-ready documentation.
6. Export all documents as needed for submission or internal audits; data ownership remains with you.

Why teams choose this solution

• Accelerates certification timelines with AI-assisted documentation.
• Reduces the cost and complexity of navigating MDR and FDA requirements.
• Delivers audit-ready documentation aligned with ISO 13485, ISO 14971, IEC 62304, IEC 62366, and more.
• Scales with team size and device complexity, from software-only to class II/III hardware devices.
• Provides clear, plain-language guidance and step-by-step workflows to avoid regulatory bottlenecks.

What’s included

• Regulatory guidance tailored to EU MDR and US FDA pathways.
• AI-powered document autopilot for MDR and FDA-compliant documentation.
• A fully functional QMS that can be configured to align with ISO 13485 and related standards.
• Documentation templates and post-market surveillance tooling.
• Case studies and customer testimonials to illustrate real-world outcomes.
• Video tutorials and extensive documentation to onboard teams quickly.

Compliance standards supported

• MDR 2017/745 (EU)
• FDA 21 CFR (US)
• ISO 13485 (QMS)
• ISO 14971 (risk management)
• IEC 62304 (software lifecycle for medical devices)
• IEC 62366 (usability)
• And additional related standards as needed for your device scope

FAQ highlights

• What is medical device certification and why is it important? Explanation of EU CE marking and US FDA approvals/clearances as prerequisites for market access.
• What is the certification process? Steps from risk class assessment, QMS setup, technical documentation, audits, and ongoing post-market requirements.
• How long does certification take? Timelines vary by class and region; timelines depend on device complexity and regulatory route.
• Is Formly right for me? Yes—designed for users with varying levels of regulatory experience, offering autopilot documentation and guided workflows.

How it helps different teams

• Startups: get to market faster with a guided, cost-effective path to certification.
• Regulatory teams: leverage AI-assisted documentation while maintaining audit readiness.
• R&D and quality teams: integrate compliance work into product development and testing.
• Enterprises: scale certification programs across multiple products with consistent governance.

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How to Get Started

• Start a free trial to explore the MDR/FDA documentation generation, QMS setup, and compliance tooling.
• Use the expert guidance to tailor the certification strategy to your device class and market goals.
• Iterate quickly with AI-assisted drafts and automated compliance updates as standards evolve.

Safety and Legal Notes

• Certification processes involve regulatory approvals and must be conducted in accordance with applicable laws and guidance documents. The platform provides guidance and automation to support compliance but does not replace regulatory judgment or official submissions.

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Core Features

• EU MDR and US FDA certification support with combined expert guidance and AI-assisted documentation
• AI-generated MDR/FDA-compliant technical documentation and QMS support
• Templates, checklists, and case studies for efficient compliance workflows
• Software, hardware, and mixed-class device support with scalable processes
• Audit-ready documentation, version control, and export capabilities
• Compliance alerts and automated updates aligned with regulatory changes
• Data ownership with exportable, vendor-lock-in-free data management
• Training resources: video tutorials, documentation, and onboarding guides