Medical Summit: Compliance for Medical Devices and Equipment

The adoption of medical devices has grown exponentially, driven by technological innovation and the increasing demand for advanced healthcare offerings. Medical devices are becoming more and more sophisticated, and this evolution needs to be accompanied by a rigorous testing and certification process to help demonstrate that they comply with applicable standards.

Understanding the key safety, cybersecurity, electromagnetic compatibility (EMC), and regulatory standards and requirements for medical devices and equipment is crucial for manufacturers and professionals.

Join our event to gain insights from UL Solutions experts.

Event attendees will:

• Gain insight into the key changes and updates in the fourth edition of IEC 60601-1.
• Learn more about the cybersecurity requirements and standards for medical devices.
• Discover more about key standards to consider and certification programs available for software as a medical device (SaMD).
• Learn about EMC and wireless testing and certification for medical devices.
• Engage in discussion and Q&A sessions addressing specific queries and concerns related to compliance.
• Have the opportunity to visit our laboratory and book a technical meeting with one of our experts.

Please find the detailed agenda below:

• 9:00am – Registration and welcome coffee
• 9:30am – Welcome and introduction of the day – Aliona Schaefer
• 9:45am – Overview of the fourth edition of IEC 60601-1 – Richard Maeder
• 10:15am – Software as a medical device (SaMD) – Thorsten Creter
• 10:45am – Cybersecurity for medical devices – Fergus Wong
• 11:15am – Coffee break
• 11:30am – Regulatory requirements for medical devices – Marcus Corzilius
• 12:00pm – EMC and wireless testing and certification for medical devices – Rachid Acharkaoui
• 12:30pm – Lunch and networking
• 1:30pm – Thriving in global regulated markets - Markus Jolic
• 2:00pm – Laboratory tour
• 2:45pm – Individual sessions with experts (limited number)
• 3:00pm – End of event

Speakers

Rachid Acharkaoui, operations manager, Consumer, Medical and Information Technologies, UL Solutions

Marcus Corzilius, managing director, Medical Device Testing, Consumer, Medical and Information Technologies, UL Solutions

Thorsten Creter, staff engineer, Consumer, Medical and Information Technologies, UL Solutions

Markus Jolic, sales manager, Product Lifecycle, UL Solutions

Richard Maeder, senior project engineer, Consumer, Medical and Information Technologies, UL Solutions

Aliona Schäfer, sales manager, Consumer, Medical and Information Technologies, UL Solutions

Fergus Wong, software solution architect, Identity Management and Security, UL Solutions