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Are you sure that your CRITIS is secure?

Editorial
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15. March 2023/by Julia Pfeffinger
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Clinical Evaluation: Seamless documentation

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13. October 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/10/shutterstock_381068455-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-10-13 13:32:472022-10-13 13:32:47Clinical Evaluation: Seamless documentation

Agile IEC 62304: How you can use the standard in the development process

Editorial
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10. August 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/08/MedizintechnikNL-SOFT-scaled.jpg 1463 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-08-10 16:56:532022-08-17 16:57:08Agile IEC 62304: How you can use the standard in the development process

General safety and performance requirements: What applies to medical devices under MDR and IVDR?

Editorial
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20. July 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/07/shutterstock_1895104081-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-07-20 18:22:072022-07-20 18:22:07General safety and performance requirements: What applies to medical devices under MDR and IVDR?

Risk management in the development process of medical devices: Beginning and end?

Editorial
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8. June 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/06/Header-RM.jpg 720 1280 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-06-08 16:42:322022-06-10 09:08:50Risk management in the development process of medical devices: Beginning and end?

Hazards and risks: This applies in risk management for medical devices

Editorial
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10. May 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/05/shutterstock_129913760-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-05-10 09:11:572022-06-10 09:21:58Hazards and risks: This applies in risk management for medical devices

How is the classification of medical devices according to MDR carried out?

Editorial
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15. March 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/03/shutterstock_519284317-scaled.jpg 1707 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-03-15 17:24:542022-03-16 11:55:23How is the classification of medical devices according to MDR carried out?

Classification of in vitro diagnostic medical devices (IVD)

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10. February 2022/by Julia Pfeffinger
https://www.riskmanager.net/byn-uploads/sites/5/2022/02/shutterstock_524351890-scaled.jpg 1536 2560 Julia Pfeffinger /byn-uploads/sites/5/2019/08/RISKMANAGER-LOGO-COLOR_II.png Julia Pfeffinger2022-02-10 10:11:132022-02-10 10:11:13Classification of in vitro diagnostic medical devices (IVD)

Merry Christmas 2021

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22. December 2021/by Julia Pfeffinger
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Usabilty Engineering – regulatorische Anforderungen und die IEC 62366

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16. December 2021/by Annika Pörner
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News

  • IEC 80001-1 Risikomanagement und KRITIS Risiko Critis RiskmanagementAre you sure that your CRITIS is secure?15. March 2023 - 14:04
  • BAYOOSOFT @ MEDICA 202231. October 2022 - 18:52
  • Medizintechnik Klinische BewertungClinical Evaluation: Seamless documentation13. October 2022 - 13:32
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