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The platform is accessible at www.ai4mdr.com and will become operational on January 15, 2025.

The experts at Regulatory Thinking® have developed the AI4MDR toolkit, a comprehensive suite of AI-driven solutions designed to expedite regulatory and certification processes for health technology businesses. Regulatory Thinking ® specializes in integrating regulatory requirements into business strategies, a methodology known as Regulatory Integrated Business Planning. This approach is taught at prestigious institutions such as ETH Zurich and the renowned 4C Accelerator in Tübingen.

The development of AI4MDR is underpinned by significant investments in time and expertise:

• Over 1,500 hours dedicated to prompt engineering
• More than 1,000 hours spent training AI assistants
• Creation of over 500 regulatory documents by AI4MDR in 2024
• Successful initiation and completion of 50 projects in 2024

AI4MDR Toolkit

AI4MDR’s platform offers a comprehensive toolkit designed to meet the diverse needs of health technology enterprises:

1. InnovAIte: Facilitates business planning through advanced AI assistants, streamlining strategic development and operational efficiency.
2. QualifAI: The virtual AI QARA team develops customized ISO 13485:2016 Quality Management Systems (QMS) and enhances implementation tailored to clients‘ specific needs, ensuring compliance and quality assurance.
3. CertifAI: Provides AI-driven tools that boost design and development, risk management, usability engineering, and clinical evaluation, accelerating the certification process and enhancing product safety and effectiveness.
4. DocuAI: Assists in the creation of technical documentation with AI support, ensuring accuracy, consistency, and compliance with regulatory standards.
5. TrAIne: Offers continuous education powered by AI to keep teams informed and compliant, providing up-to-date training and resources in the ever-evolving healthtech landscape.

These tools are engineered to simplify compliance procedures, potentially reducing certification-preparation time by up to 70%, thereby fostering innovation within the healthtech industry.

Regulatory-compliant AI Assistants

All tools have been validated against ISO 13485, ISO 14971, IEC 62366, and other pertinent standards, ensuring compliance with MDR, IVDR, and FDA regulations. They are certified as regulatory-compliant AI assistants and successfully underwent audits in 2024.

Expert Leadership Driving Innovation

At the helm of AI4MDR is Dietmar Schaffarczyk, an award-winning CEO and keynote speaker renowned for his extensive experience in regulatory standards training and auditing. Under his leadership, the AI4MDR team comprises experts in regulatory affairs, certification, Software as a Medical Device (SaMD), and artificial intelligence, ensuring that clients receive top-tier guidance and support.

Accessible Tools and Community Engagement

To demonstrate the platform’s capabilities, AI4MDR offers a complimentary tool known as the AI4MDR Milestone Planner. This resource provides users with an initial experience of how AI can transform regulatory processes and accelerate certification timelines.

Additionally, AI4MDR has established "Compliance Connect," a community platform where professionals in regulatory affairs can connect, share insights, and grow together, promoting collaboration and knowledge sharing within the industry.

For more information on AI4MDR’s AI-driven solutions and to explore their offerings, dial ++491607809628 or visit their website at www.ai4mdr.com