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Your search keyword '"Gehrmann, K."' showing total 3 results
Start Over Author "Gehrmann, K." Topic medical equipment industry
3 results on '"Gehrmann, K."'

1. Hygiene aspects when dealing with external persons in the RUMED.

Author

Alflen, M., Amman, B., Appel, T., Carter, A., Deinet, F., Diedrich, D., Diekmann, C., Fengler, T., Gehrmann, K., Hartwig, A., Grabhoff, C., Graf, J., Hartel, M., Jones, A., Kirmse, G., Kruger, S., Mann, K., Mock, I., Roitsch, M., and van Waveren, A.

Subjects
MEDICAL equipment safety measures, INDUSTRIAL hygiene, QUALITY control, OCCUPATIONAL hazards, MEDICAL equipment industry
Abstract

The article highlights the recommendations of Germany's Quality Task Force for maintaining hygiene standards when dealing with external persons in the Reprocessing Unit for Medical Devices (RUMED). Topics discussed include health risks facing external persons in the RUMED, hazard assessment as per the Biological Agents Regulation, and mandatory protective measures for external persons.

Published
2020

2. Implications of MDR for the operators of medical devices in healthcare institutions - update.

Author

Amann, B., Appel, T., Diedrich, D., Fengler, T., Forster, A., Gehrmann, K., Grabhoff, C., Hartwig, A., Jakel, C., Jones, A., Kirsme, G., Kruger, S., Metzing, J., Papadopoulos, A., van Waveren, A., and Zimmermann, U.

Subjects
MEDICAL equipment laws, MEDICAL laws, MEDICAL equipment industry, MANUFACTURING industries, LAW
Abstract

The article examines the implications of the Medical Device Regulation (MDR) for operators of medical devices in healthcare institutions in the European Union (EU). Topics discussed include important changes introduced by the MDR for medical device operators and manufacturers, implications of changes to the classification system, and the Medical Device Law Implementing Act in Germany.

Published
2020

3. Implications of MDR for the economic operator.

Author

Amann, B., Appel, T., Diedrich, D., Forster, A., Gehrmann, K., Graßhoff, C., Hartwig, A., Jones, A., Kirmse, G., Krüger, S., Metzing, J., Papadopoulos, A., van Waveren, A., and Zimmermann, U.

Subjects
MEDICAL equipment laws, ECONOMIC history, DOCUMENTATION, OBLIGATIONS (Law), MEDICAL equipment industry
Abstract

The article offers information related to the implications of Medical Device Regulation (MDR) for the economic operator. It mentions about the changes introduced by MDR for economic operators including medical device identification system changes with the incorporation of a Unique Device Identifier; and need of additional documentation obligations due to new class III devices.

Published
2020

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