Global Wireless Compliance for Medical Devices - Whitepaper

Connected medical devices offer powerful opportunities for smarter, safer healthcare - but integrating wireless technology adds layers of regulatory complexity. This whitepaper explains the essential testing and compliance requirements manufacturers must address to bring connected medical devices to global markets efficiently and confidently.

 

Why download this whitepaper? 

• Understand the additional regulatory obligations introduced by wireless functionality in medical devices 

• Learn how EU/UK, FCC, and ISED approval processes differ - and what they mean for your product 

• Gain clarity on modular vs system approvals and their impact on design decisions 

• Avoid common pitfalls that can lead to delays, redesigns, or unexpected testing costs 

• Access expert insight on risk assessments, harmonised/designated standards, and RF exposure requirements 

 

Wireless Medical Device Compliance: Abstract 

This whitepaper provides medical device manufacturers with a clear, expert-led overview of the regulatory and compliance requirements that arise when wireless technology is incorporated into medical products. Covering the European, UK, US, and Canadian approaches, it explains key concepts such as CE/UKCA marking, FCC and ISED certification, modular approvals, risk assessments, RF exposure, and the role of notified/approved bodies. By outlining the most critical considerations and potential challenges early in the development process, the guide helps manufacturers streamline certification, reduce risk, and accelerate time to market for connected medical devices. 

 

Wireless Medical Device Compliance: Excerpt 

The process of designing a wireless product is massively simplified by the proliferation of cheap and easy-to-install radio modules, which allow manufacturers to add wireless functionality to new or existing products without needing intricate knowledge of how to design and build a working radio transceiver. But the ease of creating a wireless product belies the difficulties inherent in gaining the relevant approvals for marketing such a device. It is more important than ever now for manufacturers to fully understand how the route to compliance differs 

for a radio product compared to a non-radio product, how that route changes across the globe, how this may affect a product reaching its intended markets and how using modular radios impacts the required approach.

 

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