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seleon Blog

Tag: Regulatory Affairs

seleon GmbH > Regulatory Affairs
03 Feb, 2023
Clinical Affairs, Regulatory Affairs

Periodic Safety Update Report after 2 years MDR

by Hinsija Schilling
20 Dec, 2022
Regulatory Affairs, Regulatory Affairs, Software

MedTech standards and regulations for artificial intelligence

by Hinsija Schilling
21 Oct, 2022
Regulatory Affairs

Testing for cytotoxicity: The “well-established” EN ISO 10993-5

by seleonadmin
28 Sep, 2022
Regulatory Affairs

Cleanliness of medical devices

by seleonadmin
02 Aug, 2022
Regulatory Affairs, Software

Artificial Intelligence Basics for medical technology

by seleonadmin
seleon-iso10993-23
04 Jul, 2022
Regulatory Affairs

Tests for irritation: The EN ISO 10993-23 extends the series of standards

by seleonadmin
IVDR tritt in Kraft
11 May, 2022
Regulatory Affairs

The IVDR enters into force on 26 May 2022

by seleonadmin
Blurb was ist das?
07 Apr, 2022
Regulatory Affairs

Blurb! What is that?

by seleonadmin
Lampe - Strahlung
20 Dec, 2021
Lifecycle Processes

No dirt can fight off this radiation!

by seleon
1 2 3

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Newest Articles

  • IEC PAS 63621:2026 – Data management for AI-enabled medical devices 29. April 2026
  • ISO 18969: Guarding rails for the clinical evaluation of medical devices 14. April 2026
  • IVDR 2026: Transition periods, proposal & industry status 23. March 2026
  • Digitalisation of medical technology companies 16. March 2026
Benjamin Klein
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