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Recorded version: Webinar on the synergy effects in the global approval of medical devices with wireless technologies

In this webinar, we will discuss the international recognition of test reports, in particular in accordance with EN 60601-1 and EN 62368-1.

The certification of products with integrated wireless technologies is essential for manufacturers in order to be able to sell their products on the target markets. This also applies to the medical technology sector, which is increasingly relying on wireless components.

Our webinar “Synergy effects in the global approval of medical devices with wireless technologies” offers you valuable insights into the approaches to global approval of such devices.

Learn how to master the complex challenges of product certification and how to leverage synergies for an efficient market launch. From navigating EU directives to using existing test reports for international market approval, our webinar will provide comprehensive insights and practical solutions.

The agenda of the presentation is as follows:

  • Basics of product conformity according to European law
  • Regulatory basics for products with radio interfaces
  • Basic requirements for radio equipment
  • New requirements for the cybersecurity of radio equipment and reference to the MDR
  • Regulation of medical radio products and applications in international markets

We are offering this webinar, that originally took place on June 4, 2024, in two language versions.

If you have any questions, please do not hesitate to contact us: mail@cetecomadvanced.com

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