Medical device manufacturers must show compliance to all essential requirements before placing their products in a market. With the evolution of medical equipment to connected devices, the need for guidance has increased. UL’s local presence allows us to deliver innovative, customized solutions to streamline testing, and support customers during the whole certification process.
UL Medical Compliance Day will help medical equipment manufacturers explore a variety of regulatory requirements for medical devices, including the wireless aspects. The presentations by UL experts will span from risk management for medical devices according to IEC 60601 and ISO 14971 to UKCA and MDR regulations, electromagnetic and radio requirements, and biocompatibility according to ISO 10993-1.
Event language: English
Event AGENDA – CET
09:00 – 09:30 Platform opens
09:30 – 09:45 Welcome to UL’s Medical Compliance Day
09:45 – 10:30 Wireless for medical devices 10:30 – 11:15 Risk management for medical devices according to IEC 60601 and ISO 14971
11:15 – 11:30 Break
11:30 – 12:40 UKCA and MDR
12:40 – 13:25 Lunch break
13:25 – 15:25 Afternoon sessions at choice; the three sessions will be running in parallel and will start again after one hour
- SESSION A: EMC for medical devices and in vitro diagnostic
- SESSION B: Home use medical devices
- SESSION C: Biocompatibility according to ISO 10993-1
15:25 – 15:30 Event Closing
