Wireless/radio-specific approval

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Wireless technology is increasingly being adapted for use in a wide range of medical products. Products such as medical foot switches, for example, are now more commonly produced with radio modules than without. Medical device manufacturers often use wireless modules that have already been tested and certified. This saves time and money, but requires precise instructions from the module manufacturer.

The installer needs to be familiar with the regulatory requirements of the respective markets. All technical and legal issues have to be clarified during installation. These technological developments, however, bring new challenges for medical devices manufacturers. A wireless module and the device into which it is to be integrated may individually satisfy regulations, but may be non-compliant as a combined product; this is because different laws may apply to this "new" combined product. As a result, a wide variety of laws and guidelines from different countries must be satisfied before the product can be brought to these markets, including the RED directive 2014/53/EU, FCC & ISED Regulations, MIC Japan, ANATEL, KCC and many others.

Thomas Ring SpeakerSPEAKER

Thomas Ring | Team Lead Global Market Access - Global Wireless Approvals

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Note: The video was recorded in November 2021 – no liability for any changes.


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