FormlyAI

AI-driven software solution for seamless medical device certification and compliance in the European Union and United States.

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About FormlyAI

Formly is an AI-powered platform designed to streamline the certification process for medical devices, especially for startups. It provides tools for developing and managing essential documentation, offers expert regulatory guidance, and uses AI to automate documentation creation. The platform helps companies achieve compliance with EU MDR, US FDA regulations, ISO standards, and more, enabling faster market entry and cost savings.

How to Use

Utilize Formly to develop and manage your medical device documentation, access expert regulatory advice, and leverage AI to automate writing tasks. The platform guides you through every step of certification, from assessing product risk to post-market surveillance management.

Features

Development of comprehensive Quality Management Systems (QMS)
Real-time compliance alerts and automatic updates
Streamlined document approval and revision workflows (eQMS)
Technical documentation creation and management
AI-assisted documentation generation
Access to expert regulatory guidance

Use Cases

Establishing ISO 13485 compliant QMS
Creating audit-ready technical documentation
Securing EU CE mark certification for medical devices
Managing document approvals and updates
Obtaining US FDA approval or clearance

Best For

Medical device manufacturersStartups in medical device industryRegulatory affairs specialistsQuality assurance managers

Pros

AI-driven assistance for documentation tasks
Expert regulatory guidance included
Supports multiple standards such as MDR, FDA, ISO
Reduces reliance on costly consultants
Accelerates certification timelines
Simplifies complex regulatory processes
Flexible for teams of various sizes and budgets

Cons

Initial learning curve may be required
Dependent on accurate input data for best results
AI-generated content should be carefully reviewed

FAQs

What is medical device certification and why is it essential?

In the EU, certification means obtaining the CE mark, confirming compliance with safety and environmental standards. In the US, it involves FDA approval, which can include registration, 510(k) clearance, or Premarket Approval (PMA) depending on the device class.

What steps are involved in certifying a medical device?

The process includes determining the device’s risk class, establishing a Quality Management System, preparing technical documentation, undergoing audits if necessary, and fulfilling post-market requirements.

Does Formly cover all regulatory requirements for my device?

Yes, Formly supports all essential standards needed for US and EU markets, including EU MDR 2017/745, FDA 21 CFR, ISO 13485, ISO 14971, IEC 62366, and IEC 62304.

Is Formly suitable if I am new to medical device regulations?

Absolutely! Formly is designed for beginners and experts alike. Its Document Autopilot creates compliant documents, and built-in tutorials guide you through the certification process.

When is the right time to start working on certification?

It's best to start early, right after defining your product. Beginning the certification process early helps avoid delays later on.

Can a product’s classification change over time?

Yes, a device initially classified as Class I can be reclassified to Class II or III based on additional data or changes in regulations. Review your classification regularly.

How long does medical device certification typically take?

Certification timelines vary: Class I devices may take days to months, Class II devices generally take months to years, and Class III devices often require multiple years.