Formly - Certify your medical device in the EU & US

Formly Certify your medical device in the EU & US

What is Formly?

Formly is a platform designed to manage medical device compliance, helping companies navigate the complexities of EU and US regulations. It combines expert regulatory guidance with a modern software interface. The platform helps to achieve rapid iteration by enabling agile processes, keeping fast release cycles, and offering compliance alerts along with automated updates and reminders for any new requirements.

Formly supports various standards, including MDR 2017/745 and US FDA 21 CFR, along with ISO 13485, ISO 14971, IEC 62304, and IEC 62366. The platform allows seamless data integration and export, avoiding vendor lock-in. Its AI-powered features generate MDR-compliant documentation, simplifying complex regulatory tasks. The platform is suitable for devices of any class, offering a clear roadmap and progress monitoring.

Features

Quality Management System: Create a fully ISO 13485 compliant QMS within minutes.
Technical Documentation: Effortlessly build audit-proof documentation with an AI copilot.
Document Autopilot: AI-generated MDR compliant documentation.
Compliance Alerts: Automatic updates and reminders for regulatory requirements.
Expert Guidance: Regulatory strategy and compliance support from a team of experts.
Data Integration: Seamlessly integrate existing data into the software.
Data Export: Export all data at any time with the click of a button.

Use Cases

Creating ISO 13485 compliant Quality Management Systems.
Generating technical documentation for medical device certification.
Managing post-market surveillance for medical devices.
Streamlining software validation processes.
Conducting usability evaluations for medical devices.
Performing risk management for medical devices.
Navigating EU MDR and US FDA regulatory requirements.

FAQs

What is medical device certification and why is it important for my business?

In the EU, medical device certification is a CE mark for your product, indicating it meets EU safety, health, and environmental protection requirements. In the US, it means approval by the FDA. It's essential for legal market access.
What is the certification process for medical devices?

The process involves determining product risk class, establishing a Quality Management System, creating technical documentation, undergoing an audit, and maintaining post-market requirements. Formly's software assists with all these steps.
What are the regulatory requirements for certification and does FormlyAI cover them for my device?

Formly covers all necessary standards for the US and EU markets, including MDR 2017/745, FDA 21 CFR, ISO 13485, ISO 14971, IEC 62366, and IEC 62304.
I don't know anything about medical device regulations. Is Formly right for me?

Yes, Formly's software is designed for users of all levels, including those unfamiliar with regulations. It offers guidance and automated document generation.
How long does it take to get my medical device certification?

The time varies by device class. Class I devices may take days to months, Class II devices months to years, and Class III devices multiple years. Review times also vary by regulatory body.