In the rapidly advancing field of medical technology, the integration of artificial intelligence (AI) into medical devices presents a frontier of innovation and challenge. Recognizing the critical need for comprehensive understanding of the regulatory landscape, this groundbreaking online course has been launched in collaboration with the Artificial Intelligence Quality & Testing Hub (AIQ).
This course offers a focus on the regulatory requirements for AI-based medical devices within the European Union market. Tailored for professionals navigating the complex web of EU regulations, the course provides an in-depth exploration of the essential directives, compliance strategies, and quality assurance processes necessary for market approval. With expert and cutting-edge content, participants will gain the knowledge and skills to ensure their AI medical devices meet the stringent standards of the EU, paving the way for safer, more effective healthcare solutions.
The landscape of regulatory requirements for AI-based medical devices is complex and multifaceted, encompassing a range of technical, regulative, and normative considerations. As AI continues to revolutionize the medical field, it is imperative that devices are developed and implemented within a robust regulatory framework to ensure safety, efficacy, and compliance. The European Union's Medical Device Regulation in conjunction with the General Data Protection Regulation (GDPR), provide a comprehensive set of requirements for AI in healthcare, ensuring that devices are safe and performant throughout their lifecycle. Furthermore, the EU Artificial Intelligence Act represents a significant step in the regulation of AI technologies within the European Union. Finalized in 2024, the act aims to foster trust in AI technologies by establishing harmonized rules that promote their safe and ethical use.
In practice, these regulations require developers to establish strong governance structures to oversee AI deployments, with a focus on data provenance, reliability, transparency, and understandability. This is crucial for maintaining the trust of both users and regulatory bodies. Moreover, the conformity assessment process under EU regulations demands a life-cycle approach to AI-based medical devices, which includes rigorous risk management and testing requirements. The development of international standards is also a key component of this regulatory system, providing a harmonized framework that facilitates the global distribution and acceptance of AI-based medical devices.
As the industry moves forward, it is essential for stakeholders to stay informed about the evolving regulatory landscape. Continuous education and training, such as the course described, are vital for professionals to effectively navigate these regulations and implement AI in medical devices responsibly. By understanding and adhering to these regulatory frameworks, developers and healthcare providers can ensure that AI-based medical devices meet the highest standards of safety and quality, ultimately improving patient outcomes and advancing the field of medicine.
About the trainer
Dr. Prinz works at VDE Health on the regulatory requirements for medical devices and software. Until 2012, he was employed as group leader and quality manager in the biopharmaceutical industry. Before he served as research associate at the universities of Freiburg and Utrecht. You can reach out to via LinkedIn here.
The course will explore many examples of real-world use of AI in medical devices. It will unravel the essential elements of the regulatory frameworks, including technical, regulative and normative considerations. To explore the practical techniques and industry’s best practices, Dr. Prinz has included multiple perspectives that will equip you with the knowledge and skills needed to evaluate, enhance, and ensure the regulatory requirements for AI-based medical devices. Once you have completed all modules you will receive a certificate that you can share with potential employers and your professional network.
Modules of the course
- Regulatory requirements for AI based medical devices in the EU
- Medical device software
- Medical device risk class
- Obligations of the manufacturer and product requirements
- Regulatory strategy
- Software life cycle and AI model development
- Continuous learning medical AI systems
- Risk management and cybersecurity
- Usability
- Clinical evaluation
- Post market surveillance
- Summary and final quiz
Embark on this educational journey and be at the forefront of medical device regulation in the age of artificial intelligence! You can find all further information on the homepage of the online course at our partner AIQ
AIQ online course: Introduction to regulatory requirements for AI-based medical devices
