A Wireless Medical Device Manufacturer’s Guide to Market Conformity

In today’s SMART and connected world, medical devices are no exception to the world of wireless technologies. In fact, the number of wireless medical devices is growing exponentially. As medical devices evolve, so do the risks. On one hand, we are eliminating wires and cables that previously had to be attached to patients and allowing patients much more mobility. We also have access to real-time data, patient monitoring, and in some cases, even treatment. But with so many applications for wireless medical devices, it’s critical that manufacturers understand compliance and regulations. TUV Rheinland has put together a whitepaper to help medical device manufacturers better understand what they need to know around testing and certification requirements.

Key Learning Points:

• Overview of Wireless Medical Devices
• Two Regulatory Agencies (FDA and FCC)
• Rules of Communication
• European Differences
• New challenges for wireless devices

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