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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • On-demand Webinar

Wireless Module Compliance for Medical Devices

Watch this presentation. where our experts provide a high-level overview of U.S. and EU radio approvals and how using certified radio modules can help to streamline regulatory approvals.

Medical vital signs monitor

Watch now: Wireless Module Compliance for Medical Devices

Our wireless compliance experts provide a high-level overview of U.S. and EU radio approvals and how using certified radio modules can help to streamline regulatory approvals.

Webinar date: July 14, 2022

Speaker: Mark Briggs, director of UL Verification services wireless certification program

 

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

Watch this presentation to learn about:
  • U.S. Federal Communications Commission (FCC) modular requirements, including whether you need to recertify a host product if the radio frequency (RF) module has FCC approval, and what you can do if you cannot meet the RF module conditions.
  • Information on the EU Radio Equipment Directive requirements you need to meet at the system level when utilizing an RF module with a CE marking.
  • A look at key countries in Latin America, Asia and Europe, and which requirements may allow leveraging a modular approach.
  • A short list of essential module features to keep the radio regulatory approval overheads to a minimum for medical devices.

 

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