Webinar: Wireless module compliance for medical devices: what you need to know


In our first wireless compliance webinar, we highlighted the two main pathways to medical device wireless compliance: modular approval and system approval. Modular approval can be faster, more cost effective, and more adaptable than the system approach. However, it comes with regulatory implications that can vary from one market to the next.

In this webinar, wireless compliance experts at UL provide an in-depth look at modular approval requirements so you can determine the best compliance strategy for your product. Here’s what you will learn:

  • US FCC Modular requirements, including whether you need to recertify a host product if the RF module has FCC approval and what you can do if you cannot meet the RF module conditions;
  • EU Radio Equipment Directive requirements and what additional requirements you need to meet when utilizing an RF Module with CE Marking;
  • A look at key countries within Latin America, Asia, and Europe that will leverage a modular approach.

About the presenters:

Mark Briggs is the Director of UL Verification Services Wireless Certification program covering certification for US (FCC), Canada (ISED), and Type Examination. Mark has been with UL since 2011, with a gap year at Intel where he worked on wireless charging. Mark has more than 20 years of experience in EMC covering EMC and wireless testing, creating test software for EMC and DFS tests and performing Certification Body functions for FCC, Industry Canada and the EU. He participates in several Working Groups for the wireless test standards ANSI C63.10 and ANSI C63.26. Mark is also Secretary for the TCB Council. Mark holds an MS in EMC from the University of York in the UK and is a Chartered Engineer and NARTE Certified EMC Engineer.

Bob DeLisi, Principal Engineer, Consumer Technology Division, has been with UL for 29 years and has been involved in all facets of the UL EMC/Wireless business from testing to lab management. He participates on ANSI Accredited Standards Committee C63™ and is the current Chair of Subcommittee 4 for Wireless and ISM Devices. He also actively participates on Subcommittee 1 (Techniques and Development) and Subcommittee 6 (Accreditation/Conformity Assessment) and Subcommittee 8 (Medical Devices). He is also a member of the IECEE’s Committee of Testing Laboratories Expert Task Force, CLT-EFT 10 for EMC. Bob holds a Bachelor of Electrical Engineering and is a NARTE Certified EMC Laboratory Engineer.