Formly

Formly is an AI-powered tool that streamlines medical device certification and compliance. It helps manufacturers achieve regulatory approval 5-10x faster and save up to $250k.

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At a glance

Pricing

Paid · Custom

Free tier

API

Skill level

Technical

About

What is Formly?

Formly is an AI-powered software designed to accelerate medical device certification and ensure compliance with regulatory standards. It combines human expertise with AI efficiency to guide manufacturers through complex processes like ISO 13485, 21 CFR, MDR 2017/745, and IVDR 2017/746. The platform offers a clear certification roadmap, covering essential steps such as clinical evaluation, risk management, traceability matrix, and post-market surveillance. Formly aims to eliminate resource drain by providing comprehensive guidance, dedicated experts, and automated compliance workflows, allowing companies to focus on innovation. It supports various product stages and offers predictable pricing models, including fixed fees for pre-certification and annual fees for ongoing compliance.

Best used for

Ideal for medical device manufacturers who need to navigate complex regulatory landscapes, accelerate certification for FDA, EU MDR, and IVDR, and maintain continuous compliance. Especially valuable for startups and established companies looking to launch life-changing technology faster and more cost-effectively.

Common actions

manage medical device compliance

accelerate regulatory approval

streamline certification process

ensure quality management

Capabilities

Key features

Medical device certification
Regulatory compliance guidance
Quality Management System
Technical Documentation
Post-Market Surveillance
Dedicated expert support
Multi-market compliance

Target Audience

doctor

Integrations

Not yet documented

Pricing & Plans

Paid · Custom

Not publicly disclosed. Check formly.ai for current pricing.

FAQs

What regulatory standards does Formly support?

Formly provides comprehensive support for major medical device regulatory standards, including ISO 13485, 21 CFR (FDA), MDR 2017/745 (EU Medical Device Regulation), and IVDR 2017/746 (EU In Vitro Diagnostic Regulation). It also covers associated consensus standards to ensure complete compliance.

How does Formly combine human expertise with AI?

Formly integrates human regulatory experts with AI efficiency to offer a comprehensive product. The AI streamlines compliance workflows and identifies requirements, while dedicated human experts provide guidance, review documentation, and ensure accuracy, addressing any challenges that arise.

What are the pricing models for Formly's services?

Formly offers two primary pricing models: a Pre-Certification Fixed Fee for getting devices to market quickly, covering all necessary certification aspects, and a Post-Certification Annual Fee for ongoing compliance management. Both are tailored to specific needs, from self-managed to fully outsourced support.

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