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 — all must meet the relevant regulations. With hundreds of pieces of medical equipment in hospitals using Radio Frequency Identification (RFID) tracking tags, it’s hard to imagine a medical device in the modern day that doesn’t make use of wireless technology.
This 30-minute webinar will help attendees understand the relevant testing and certification requirements their products must meet.
Topics explored will include:
- Essential requirements under the Radio Equipment Directive (Article 3)
- Health and safety considerations such as specific absorption rate (SAR) testing
- What the new cyber security requirements mean for industry companies
- FCC and ISED approval routes and rules
An audience Q&A session will follow the technical presentation.
Speaker:
Alex Toohie, Technical Solution Manager, Element
Alex Toohie serves as a Technical Solution Manager at Element. He has worked in regulatory compliance for more than a decade, both within Element’s Connected Technology & Mobility group and in industry as a Compliance Manager for a global leader in wireless intruder and fire alarm systems. In his current role, 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.
Moderator:
Amanda Hosey, Editor, SAE Media Group
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