FormlyAI

FormlyAI: AI-Powered Regulatory Compliance for Medical Devices

What is FormlyAI? FormlyAI is a virtual chief regulatory officer designed to help medical device manufacturers navigate the complex world of regulatory compliance. It combines AI-driven tools with human expertise to streamline the certification process, ensure ongoing compliance, and accelerate time to market.

How does FormlyAI work?

FormlyAI offers a comprehensive platform that covers all aspects of medical device compliance, including:

• Certification Strategy: Clear roadmap for identifying and implementing all compliance requirements for your device, regardless of complexity.
• Regulatory Documentation: Assistance with creating and managing necessary documentation.
• Audit Support: Preparation and support during audits.
• Clinical Evaluation: Guidance on proving the safety and effectiveness of your medical device.
• Risk Management: Identifying, assessing, and mitigating potential risks.
• Traceability Matrix: Linking requirements to design, testing, and verification.
• Post-Market Surveillance: Monitoring device performance and safety after it's on the market.
• Training: Ensuring employees are properly trained.
• User Needs: Identifying and prioritizing user needs.

The platform adapts to your existing compliance workflows, providing complete guidance without costly detours. It works for any product stage and is designed to help you stay compliant forever, allowing you to scale your product without scaling your team.

Why is FormlyAI important?

Medical device compliance is a critical but often challenging process. FormlyAI simplifies this process by providing:

• AI Efficiency: Automates many of the time-consuming tasks associated with compliance.
• Human Expertise: Access to a team of seasoned regulatory experts.
• Comprehensive Coverage: Supports ISO 13485, 21 CFR, MDR 2017/745, IVDR 2017/746, and associated consensus standards.
• Predicable Pricing: Transparent, fixed-fee pricing for pre-certification and annual fees for post-certification support.

Who is FormlyAI for?

FormlyAI is ideal for:

• Startups and Small Businesses: Streamlines compliance, allowing them to focus on innovation.
• Next-Gen Medical Device Companies: Supports implants, digital therapeutics, cancer diagnostics, and more.
• Companies Seeking Multi-Market Compliance: Helps navigate compliance across continents and multiple markets.

How to use FormlyAI?

1. Request a Demo: Contact FormlyAI to schedule a demo and discuss your specific needs.
2. Choose a Plan: Select either the Pre-Certification or Post-Certification plan based on your product stage.
3. Onboard and Implement: Work with FormlyAI's experts to implement the necessary compliance measures.
4. Stay Compliant: Utilize the platform for ongoing compliance support and updates.

Key Features and Benefits:

• Virtual Chief Regulatory Officer: Providing expert guidance at every stage.
• AI-Driven Efficiency: Automating tasks and reducing resource drain.
• Comprehensive Support: Covering a wide range of compliance requirements.
• Scalable Solution: Adapting to your needs as your company grows.
• Happy Customers: Positive testimonials from companies who have successfully achieved certification with FormlyAI.

Customer Testimonials:

• Philipp Piroth, Co-Founder & CEO @ Myoact: "We know we have the back office covered with Formly. They are hands on and make our medical device compliance easy."
• Anina Langhans, Co-Founder & Product Lead LipoCheck: "Our package with Formly is exactly what we wanted and what we needed —no BS, no fluff. Formly's services are straight to the point and the team is so pleasant to work with."
• Dr. Julian Kruse, Co-Founder & CMedO @ coobi: "The more I work on Formly the more it amazes me. Hats off for making a product that is easy to use and immediately brings users insane value!"

What problems does FormlyAI solve?

FormlyAI addresses several critical challenges in the medical device industry:

• Complexity of Regulations: Simplifies the complex web of medical device regulations.
• High Costs of Compliance: Reduces the costs associated with traditional compliance methods.
• Resource Constraints: Allows companies to scale without proportionally increasing their compliance team.
• Time to Market Delays: Accelerates the certification process, getting products to market faster.

Conclusion:

FormlyAI is revolutionizing medical device compliance by combining the power of AI with expert human guidance. It's an invaluable tool for any company looking to navigate the regulatory landscape efficiently and effectively, ensuring patient safety and product success. For medical device manufacturers, FormlyAI can dramatically simplify the process of navigating the complex regulatory environment while minimizing costs and time to market.