The future is wireless and the future of medical devices even more so. From wearable medical technologies, which now come with embedded Bluetooth, wireless charging, and even 4G and 5G; to tried-and-tested technologies like defibrillators which now have GPS or Wi-Fi, which must meet the relevant regulations.

 

Why should I attend?

With hundreds of pieces of medical equipment in hospitals with Radio Frequency Identification (RFID) tracking tags; it’s hard to imagine a medical device in the modern day which wouldn’t have some sort of wireless technology. This session will help you understand all the relevant testing and certification requirements your products must meet.

The webinar is suitable for those who already have products on the market, or have new products in the research or development stage. During the session, Alex will give an overview of EU, UK, US and Canadian requirements. Finally, the topic of radio modules within medical devices will be covered, including CE Marking, UKCA Marking, FCC ID (Federal Communications Commission Identifier) and ISED ID (Innovation, Science and Economic Development Canada).

What you’ll learn

  • The Essential requirements under the Radio Equipment Directive (Article 3)
  • An understanding of health and safety considerations, such as Specific Absorption Rate (SAR) testing
  • What the new cyber security requirements mean for you
  • The FCC and ISED approval routes and rules

Register today

Register via the link below to secure your spot on this webinar. 

Alex Toohie has been working in regulatory compliance for more than a decade, both within Element’s Connected Technology & Mobility group and in 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 (covering RED, EMCD, CPR, ATEXD, RoHSD, etc.), FCC and ISED, as well as the evolving global product cyber security requirements, to help manufacturers find the most effective and cost-efficient certification paths for complex and varied radio equipment.

Register now for the webinar