Wireless features are becoming standard in modern medical devices, but they add complexity to product safety compliance across regions and regulatory frameworks. This webinar explores how to identify the relevant testing and certification requirements for connected medical devices, including products already on the market and those in development.
With hundreds of pieces of medical equipment in hospitals equipped with radio frequency identification (RFID) tags, it’s difficult to imagine a modern medical device that wouldn’t have some form of wireless technology. The featured speakers will provide an overview of EU, UK, US and Canadian requirements relevant to connected medical devices, with practical context for teams that already have products on the market or are planning market access and compliance.
Lastly, this webinar will also explore radio modules within medical devices, including CE Marking, UKCA Marking, FCC ID (Federal Communications Commission Identifier) and ISED ID (Innovation, Science and Economic Development Canada).
Register for this webinar to learn how product safety compliance applies to connected medical devices and the testing pathways that support market access.
Speaker
Alexander Toohie, Technical Solution Manager, Element
With over 10 years of experience, Alex Toohie supports global manufacturers with navigating wireless and radio equipment compliance and overcoming complex technical challenges.
He has been working in regulatory compliance for more than a decade, both within Element’s Connected Technology & Mobility group and in the industry as Compliance Manager for a global leader in wireless intruder and fire alarm systems.
As Element’s Technical Solution Manager, Alex draws on a wealth of experience in UKCA and CE marking (including RED, EMCD, CPR, ATEXD, RoHSD, etc.), FCC and ISED, as well as CPR certification, NRTL registration and regulatory approvals in Japan, China and Korea. He also specializes in the evolving global product cybersecurity requirements, to help manufacturers find the most effective and cost-efficient certification paths for complex and varied radio equipment.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Medical Device Designers
- Medical Device Manufacturers
- Medical Device Quality and Compliance Managers
What You Will Learn
Attendees will gain insights into:
- The essential requirements under the Radio Equipment Directive (Article 3)
- Health and safety considerations, such as Specific Absorption Rate (SAR) testing
- The new cybersecurity requirements
- The FCC and ISED approval routes and rules
Xtalks Partner
Element Connected Technologies & Mobility
Element Connected Technologies & Mobility, a specialized business unit of Element Materials Technology, is a leading provider of testing, inspection, and certification services for connected devices and mobility solutions. Operating from 17 specialized laboratories across the United States, United Kingdom, Germany, China, South Korea, and Japan, our team of 1,200+ technology experts help manufacturers accelerate time-to-market for consumer electronics, IoT devices, autonomous vehicles, and medical equipment. We provide comprehensive testing and certification services that ensure products meet international standards for connectivity, interoperability, and safety. As part of Element’s global platform, we combine deep connected technology expertise with the broader capabilities of one of the world’s leading testing partners.
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