Date & Time
Starts
Nov 21, 2024 9:00am CET
Ends
3:00pm CET
Location
UL Solutions - UL INTERNATIONAL DEMKO A/S
Borupvang 5A
2750 Ballerup, Denmark
Language
English
The development of medical devices and their underlying technology plays a crucial role in modern healthcare, enhancing the ability to diagnose, treat and monitor patients with greater precision and efficiency.
Advances in areas such as imaging, implantable devices and digital health applications have transformed patient outcomes and improved the quality of care globally.
However, given their direct impact on human health and safety, it is fundamental that medical devices adhere to stringent standards and regulatory requirements; 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 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 – Francesco Marenoni
- 9:45am – Overview of the fourth edition of IEC 60601-1 – Mona Nielsen
- 10:15am – Software as a medical device (SaMD) – Alex Martin Smith
- 10:45am – Cybersecurity for medical devices – Jose Manuel Capella Rodriguez
- 11:15am – Coffee break
- 11:30am – Regulatory requirements for medical devices – Alex Martin Smith
- 12:00pm – EMC and wireless testing and certification for medical devices – Joaquin Gomez Serrano
- 12:30pm – Lunch and networking
- 1:30pm – Human Factors Research & Design services – Flemming Flindt
- 2:15pm – Individual sessions with experts (limited number)
- 3:00pm – End of event
Speakers
Jose Manuel Capella Rodriguez, senior advisor, Identity Management and Security, UL Solutions
Flemming Flindt, sales director, Human Factors Research & Design, UL Solutions
Joaquin Gomez Serrano, senior product specialist, Consumer, Medical and Information Technologies, UL Solutions
Francesco Marenoni, sales director, Consumer, Medical and Information Technologies, UL Solutions
Alex Martin Smith, senior product specialist, Consumer, Medical and Information Technologies, UL Solutions
Mona Nielsen, senior staff engineering associate, Consumer, Medical and Information Technologies, UL Solutions
Join us!
Join our experts as they offer an overview of key safety, cybersecurity, EMC, and regulatory standards and requirements for medical devices and equipment.