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WATCH NOW: Navigating Regulatory Requirements for Wireless Medical Devices

Cellular technology adds exciting new possibilities for healthcare but can also bring regulatory burden. When you incorporate a wireless module into your medical device, you must comply with wireless technology Type Approval requirements that apply in over 100 countries. And, there is no one-size-fits-all approach, as regulatory and testing requirements can vary by market based on your device’s technology.

Despite these obstacles, the benefits of cellular technology outweigh the challenges of certifying a wireless product, even in the most challenging markets. In this one-hour webinar, wireless compliance experts at UL discuss regulatory requirements for cellular and wireless devices in major markets. You will learn: 

  • How technology affects your regulatory requirements
  • Key differences between a host and a module, and options you have based on the type of module selected
  • Overview of testing requirements for wireless devices
  • Introduction to US (FCC) and European Union (Radio Equipment Directive) standards
  • Compliance routes for wireless Type Approvals when selling globally

ABOUT THE PRESENTERS:
Nicole Tatum is the North American Global Market Access (GMA) Operations Manager in UL’s Consumer Technology division, based in Research Triangle Park, NC. In this role, Ms. Tatum and her team help and support manufacturers with global compliance strategies and leverage UL’s global footprint to ensure smooth product launches in target markets. She received her Bachelor of Science in Electrical Engineering from The University of North Carolina at Charlotte and has worked at UL for 21 years.

Seth Bafford is the North American Strategic Account Manager for Global Radio Type Approvals, EMC and Product Safety for ITE/Consumer electronic devices. He has been in B2B customer relationship management and sales for nine years, seven of which at Underwriters Laboratories Consumer Technology Division.