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The advances in wireless technologies is offering medical device manufacturers enormous potential for innovation. However, in the wake of these new technologies, the medical device industry is also facing new and additional requirements. In addition to the relevant medical device directives, the radio-controlled devices also need to meet the requirements for radio equipment in the individual jurisdictions, which include the R&TTED or RED Directives in the EU, the FCC/ISED requirements in the USA and Canada, the MIC requirements in Japan, and the ANATEL requirements in Brazil.
TÜV SÜD’s team of international experts is highly familiar with these requirements and can provide valuable support. TÜV SÜD’s new testing laboratory in Straubing also offers many possibilities for testing the function and safety of wireless products. Interested in learning more about the international registration of wireless medical devices? Please contact our specialists Thomas Ring or our customer service.
Points to consider right from the start for wireless medical devices to ensure successful registration:
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