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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

  • Keeping pace with Swiss medical device regulation 23. June 2026
  • PMS, PMCF and Trending under the MDR 2. June 2026
  • Cybersecurity requirements within a QMS 19. May 2026
  • Internal Performance Studies under the IVDR, Annex XIII 19. May 2026
Benjamin Klein
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