Date & Time
Starts
Oct 8, 2025 9:30am CEST
Ends
4:15pm CEST
Location
UL Solutions
Via Delle Industrie 1
20061 Carugate (MI)
Language
English
Entering European and global markets
Medical devices are becoming increasingly sophisticated, and this evolution needs to be accompanied by a comprehensive testing and certification process to help demonstrate that they comply with applicable standards.
It is crucial for manufacturers and professionals to understand the key safety, cybersecurity, electromagnetic compatibility (EMC), regulatory standards and requirements for medical devices and equipment entering European and global markets.
Event attendees will:
Get an overview of the safety standard IEC 60601-1 -2:2014, including changes and updates to its fourth edition
Learn more about Software as a Medical Device (SaMD)
Review the key EMC and wireless testing and certification requirements for medical devices
Discuss the regulatory programs for North American and European market access
Learn about cybersecurity requirements and standards for medical devices
Have the opportunity to visit our laboratory and book a short technical meeting with one of our experts
Please find the detailed agenda below:
| Time | Event |
|---|---|
| 09:30 a.m. | Registration and welcome coffee |
| 10:00 a.m. | Welcome and introduction of the day – Michela Trevisan |
| 10:15 a.m. | Overview of the safety standard IEC 60601 and a deep dive into the changes and updates to its fourth edition – Mario Zucchi |
| 11:15 a.m. | Coffee break |
| 11:30 a.m. | Examples of the safety standard IEC 60601 applications on medical devices – Mario Zucchi |
| 12:00 p.m. | Software as a Medical Device (SAMD) – Alessandra Missaglia |
| 12:30 p.m. | Lunch |
| 13:30 p.m. | EMC testing and certification for medical devices – Roberto Colombo |
| 14:15 p.m. | Regulatory programs – Caterina Puddu |
| 15:00 p.m. | Coffee break |
| 15:15 p.m. | Cybersecurity for medical devices – Fergus Wong |
| 15:45 p.m. | Laboratory tour – Roberto Colombo |
| 16:15 p.m. | Short technical meetings and coffee break |
Meet our experts
Roberto Colombo, Operations manager, Consumer, Medical and Information Technologies, UL Solutions
Alessandra Missaglia, Staff engineer, Consumer, Medical and Information Technologies, UL Solutions
Caterina Puddu, Senior project engineer, Consumer, Medical and Information Technologies, UL Solutions
Michela Trevisan, Senior sales manager, Consumer, Medical and Information Technologies, UL Solutions
Fergus Wong, Device security product specialist, Consumer, Medical and Information Technologies, UL Solutions
X
Join our event to gain insights from UL Solutions experts.
Please wait…
Characters remaining