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seleon Blog

Category: Clinical Affairs

seleon GmbH > Clinical Affairs
07 Aug, 2026
Clinical Affairs

Clinical evaluation according to Article 61(10)

by Hinsija Schilling
02 Jun, 2026
Clinical Affairs

PMS, PMCF and Trending under the MDR

by Hinsija Schilling
19 May, 2026
Clinical Affairs

Internal Performance Studies under the IVDR, Annex XIII

by Hinsija Schilling
14 Apr, 2026
Clinical Affairs

ISO 18969: Guarding rails for the clinical evaluation of medical devices

by Hinsija Schilling
21 Nov, 2025
Clinical Affairs

Performance evaluation according to IVDR: Clinical performance

by Hinsija Schilling
14 Jul, 2025
Clinical Affairs

Performance evaluation according to IVDR: analytical performance

by Hinsija Schilling
20 May, 2025
Clinical Affairs, Lifecycle Processes, Regulatory Affairs

PMCF for legacy devices and early MDR products

by Hinsija Schilling
07 May, 2025
Clinical Affairs, Health Software, Lifecycle Processes, Regulatory Affairs, Sustainability

Microplastics in medical devices: Regulated by REACH

by Hinsija Schilling
02 Apr, 2025
Clinical Affairs, Regulatory Affairs

Performance evaluation according to IVDR: Requirements and evidence

by Hinsija Schilling
04 Feb, 2025
Clinical Affairs, Regulatory Affairs

Symbols on medical devices and in-vitro diagnostics

by Hinsija Schilling
1 2 3 … 5

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Newest Articles

  • Reducing the use of animal testing in the context of biological assessments 14. August 2026
  • MDSAP – One audit for the (medical technology) world? 11. August 2026
  • Update: EN ISO 10993-1:2025 – harmonised under MDR June 11. August 2026
  • Clinical evaluation according to Article 61(10) 7. August 2026
Benjamin Klein
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Tel.: +49 152 578 103 56
Email: info@seleon.com
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