Date & Time
Starts
Mar 5, 2025 8:30am CET
Ends
3:30pm CET
Location
UL Solutions Bolero Office Point 2
Równoległa 4, 02-232 Warszawa, Poland
Language
English
The adoption of medical devices has grown exponentially, driven by technological innovation and the expanding demand for advanced healthcare offerings. Medical devices are becoming increasingly 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), regulatory standards and requirements for medical devices and equipment that are entering global markets 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 about the cybersecurity requirements and standards for medical devices and the certification programs available for software as a medical device (SaMD).
- Discover the EMC and global market access wireless testing and certification paths.
- Find out how the ASCA and MDSAP programs can make the North American market access much easier.
- Have the opportunity to visit our laboratory and book a technical meeting with one of our experts.
Please find the detailed agenda below:
| Time | Title | Speakers |
|---|---|---|
| 8:30am | Registration and welcome coffee | |
| 9:00am | Welcome and introduction of the day | Malgorzata Chocholska and Katarzyna Krypa |
| 9:30am | Overview of the fourth edition of IEC 60601-1 | Grzegorz Kowalski |
| 10:00am | Software as a Medical Device (SaMD) | Krzysztof Wasilewski |
| 10:30am | Cybersecurity for medical devices | Jose Manuel Capella |
| 11:00am | Coffee break | |
| 11:15am | EMC and Global Market Access wireless testing and certification paths for medical devices | Joaquin Gomez Serrano and Pilar Gomez |
| 12:15pm | North American market access with ASCA and MDSAP programs | Boguslawa Nadworska |
| 12:30pm | Lunch | |
| 1:30pm | Emergo by UL: your market access partner | Katarzyna Kalinowska |
| 2:00pm | Laboratory tour | Bartlomiej Zmijewski and Paweł Wasiak |
| 3:00pm | Individual sessions with experts (limited number) |
Speakers
- Jose Manuel Capella, senior security advisor, Identity Management and Security, UL Solutions
- Malgorzata Chocholska, sales manager, Consumer, Medical and Information Technologies, UL Solutions
- Joaquin Gomez Serrano, senior product specialist, Consumer, Medical and Information Technologies, UL Solutions
- Pilar Gomez, senior product specialist, Consumer, Medical and Information Technologies, UL Solutions
- Katarzyna Kalinowska, senior sales executive, Advisory Product Lifecycle, UL Solutions
- Grzegorz Kowalski, lead project engineer, Consumer, Medical and Information Technologies, UL Solutions
- Katarzyna Krypa, inside sales executive, Consumer, Medical and Information Technologies, UL Solutions
- Boguslawa Nadworska, senior product specialist, Consumer, Medical and Information Technologies, UL Solutions
- Paweł Wasiak, project engineer, Consumer, Medical and Information Technologies, UL Solutions
- Krzysztof Wasilewski, operations manager, Consumer, Medical and Information Technologies, UL Solutions
- Bartlomiej Zmijewski, laboratory manager, UL Solutions
Join us!
Join us for an overview of safety, cybersecurity, EMC, global market access and regulatory standards and requirements for medical devices and equipment.