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seleon Blog

Category: Lifecycle Processes

seleon GmbH > Lifecycle Processes
Cockpit - Flugzeug - Piloten - Instrumente
05 Sep, 2018
Lifecycle Processes

Design Controls for Medical Devices: A quick guide

by seleon
Wand - Klettern - Blau
01 Sep, 2018
Lifecycle Processes, Regulatory Affairs

FDA approval: The path of your medical device to the USA

by seleon
Puzzle - Spiel - Teamwork
29 Aug, 2018
Clinical Affairs, Lifecycle Processes, Regulatory Affairs, Software

General Safety and Performance Requirements under the MDR

by seleon
Sprint - Rennen - Sieger
27 Aug, 2018
Lifecycle Processes, Regulatory Affairs

Declaration of conformity for medical devices

by seleon
Türen - Farbig
25 Aug, 2018
Lifecycle Processes, Regulatory Affairs

Conformity assessment procedures for medical devices

by seleon
Audit - cfr
21 Aug, 2018
Lifecycle Processes

21 CFR 820: FDA Quality System Regulation

by seleon
Tastatur - Farbig
15 Aug, 2018
Lifecycle Processes, Regulatory Affairs

Usability Engineering & the IEC 62366-1 for Medical Devices

by seleon
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Newest Articles

  • 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
  • Keeping pace with Swiss medical device regulation 23. June 2026
Benjamin Klein
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