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Transfer of innovations and research results through standards into healthcare

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KLAUS NEUDER: "Innovations and Research results can be the basis for standards in healthcare and an improvement for patient care. On the other hand the healthcare sector, especially medical, is highly regulated by law (e.g. in the EU Medical Device Regulation). The goal is to find a balance between these two sides."

Innovations and Research results can be the basis for standards in healthcare and an improvement for patient care. On the other hand the healthcare sector, especially medical, is highly regulated by law (e.g. in the EU Medical Device Regulation). The goal is to find a balance between these two sides.

The application of standards is voluntary – however standards are necessary to support the regulatory framework and speed up „time to market“ and support the discussion between Manufacturers, Notified Bodies and Regulators. These are a platform of trust for all involved parties.

VIDEOZÁZNAM

Klaus Neuder

Deutsche Kommission Elektrotechnik
Klaus Neuder is Head of Health in DKE (Deutsche Kommission Elektrotechnik), the German Standardization Body for electrotechnics and information technology. During his professional career he started in Fresenius in the development department and managed infusion technology. Further steps were marketing and service for medical technology. He became an valuable expert and convenor in IEC SC62D (electromedical equipment). Since 2002 he is with DKE and manage the standardization covering active medical equipment, active implants, risk management, connected medical devices and software. In 2017 he became Chairman of IEC SC62D and in 2022 Chairman of Cenelec TC 62.
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