FormlyAI

The shortest path to medical device approval starts here.

Contact for Pricing

Description

FormlyAI combines artificial intelligence with leading regulatory expertise to accelerate and simplify the certification process for medical devices. The platform supports complete compliance for standards such as ISO 13845, 21 CFR, MDR 2017/745, and IVDR 2017/746, ensuring that regulatory requirements are fully identified and implemented, regardless of product complexity.

With adaptable workflows, continuous compliance monitoring, and dedicated human support, FormlyAI enables companies to bring medical technologies to market faster and maintain long-term regulatory adherence across regions. The solution eliminates resource drain and scales with your business, providing a reliable pathway to certification and ongoing device management.

Key Features

Complete Certification Coverage: Supports ISO 13845, 21 CFR, MDR 2017/745, and IVDR 2017/746 standards
Clear Certification Roadmap: Provides step-by-step compliance requirements for any device complexity
AI and Human Expertise: Combines automation with dedicated regulatory professionals
Seamless Workflow Integration: Adapts to existing company processes and documentation
Multi-Device Management: Manage multiple medical devices simultaneously
Multi-Market Compliance: Fast-track certification for different international regulations
Fully Managed Regulatory Support: Includes technical documentation, QMS, eQMS, audit support, PRRC
Ongoing Compliance Monitoring: Post-market surveillance, complaint handling, change management
Employee Training: Ensures staff remain compliant with regulatory training requirements

Use Cases

Accelerating medical device certification and market entry
Managing regulatory compliance for multiple medical devices
Preparing documentation and systems for FDA, MDR, or IVDR approval
Maintaining post-market surveillance and compliance reporting
Ensuring staff training in regulatory requirements
Scaling regulatory oversight for startups and established companies

Frequently Asked Questions

What's your pricing structure and payment terms?

FormlyAI offers a pre-certification fixed fee and an annual fee for ongoing compliance services. Pricing is tailored to each company's requirements and provided on request.

How long does the certification process typically take?

Timelines vary by device and regulatory pathway, but FormlyAI is designed to accelerate compliance and reduce time to market compared to traditional approaches.

What exactly is included in your service package?

The package covers end-to-end regulatory support, including quality management systems, technical documentation, audit support, dedicated regulatory experts, post-market surveillance, and employee training.

Can your platform integrate with existing tools?

Yes, FormlyAI is built to adapt to your company's existing compliance workflows and integrate with current documentation and QMS systems.

Can you work with our existing documentation/QMS?

FormlyAI supports integration with existing documentation and quality management systems to streamline compliance processes without disruption.