Electromagnetic Compatibility and Radio Compliance for Medical Devices

Is a team designing a medical device and seeking guidance on electromagnetic compatibility regulatory requirements? Or is there a need to integrate a radio into the device, necessitating an understanding of Federal Communications Commission (FCC) and The United States Food and Drug Administration (FDA) regulations? Would less regulatory pushback accelerate the time to market? Is there an interest in acquiring more knowledge and guidance for this process?

In this webinar, the expert speakers will discuss basic electromagnetic compatibility requirements under IEC 60601-1-2, the growing field of radio frequency identification (RFID) immunity, wireless coexistence and more.

Connected medical devices have additional challenges and requirements to meet before going to market. Radio regulations need to be addressed and a risk assessment is necessary to determine how the radio functions affect essential performance. In this webinar, the attendees will learn how ANSI C63.27 can be used to tackle the FDA’s interest in wireless coexistence and how AAMI TIR69 covers how to assess risks.

Medical devices also need to address differences between basic safety, essential performance and intended use. There are different requirements for various functions, many of which need different types of testing. It can be challenging to navigate these complex requirements and which requirements take precedence. This webinar is designed to help simplify this process.

Join this webinar to learn about electromagnetic compatibility for medical devices. The experts will cover best practices when integrating radios into a medical device, which will help create a path to ensure a smooth regulatory process. In the USA, medical devices need to meet both FCC and FDA requirements, and this webinar covers how to achieve this goal.

Speaker

David Schaefer, EMC Technical Manager, Element Materials Technology

David Schaefer is an EMC Technical Manager for Element Materials Technology’s Connected Technologies and Mobility business unit. He graduated from North Dakota State University with a degree in Electrical Engineering and has nearly 20 years’ experience in EMC, radio and product compliance. David was the Chapter Chair of the Twin Cities IEEE EMC Society and is active in ANSI C63 subcommittees 1, 5, 6 and 8. He was the Vice-Chair of the working group that published ANSI C63.24 In-Situ RF Immunity Evaluation of Electronic Devices and Systems and is a member of the working group developing the new standard ANSI C63.33 Immunity of Portable Medical Devices to Electronic Article Surveillance (EAS) Systems. David was also a member of the working group that released the Second Edition of ANSI C63.27 on Wireless Coexistence, and a Member of the MDIC 5G-enabled Healthcare Technologies Working Group. He gave a presentation at the 2020 Virtual IEEE EMC+SIPI Symposium and was a member of an “Ask the Experts” panel at the 2023 IEEE EMC+SIPI Symposium.

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