The white paper "Synergy effects in the global approval of medical devices with wireless technologies" highlights the challenges and solutions for the certification and international recognition of medical devices with integrated wireless technologies. It discusses the requirements of the EU RED Directive and the relevance of the EN 60601-1 and EN 62368-1 standards for the safety testing of these devices. It also discusses the importance of international recognition of test reports and the need for adapted approval strategies for different markets. The white paper offers valuable insights for manufacturers who want to market their medical devices worldwide.
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