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Regulatory Affairs Blog

Category: Regulatory Affairs

seleon GmbH > Regulatory Affairs
20 Dec, 2022
Regulatory Affairs

Artificial Intelligence Basics for medical technology

by Hinsija Schilling
21 Oct, 2022
Regulatory Affairs

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

by Alexandra Grosu
28 Sep, 2022
Regulatory Affairs

Cleanliness of medical devices

by Alexandra Grosu
eIFU-Pflicht-seleon
17 Aug, 2022
Regulatory Affairs

Electronic instructions for use – The hidden duty of MDR

by seleonadmin
02 Aug, 2022
Regulatory Affairs

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
Kind - Brille - Freude
28 Oct, 2021
Lifecycle Processes, Regulatory Affairs

Has the penny dropped?

by seleon
Dschungel - Bäume - Wald
30 Sep, 2021
Clinical Affairs, Health Software, Lifecycle Processes, Regulatory Affairs

The Way out of the MDR standards jungle

by seleon
Mind the gap - Bahn
26 Jul, 2021
Lifecycle Processes, Regulatory Affairs

Caution, distributor! Or manufacturer after all …?

by seleon
1 2 3 … 6

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Newest Articles

  • Artificial Intelligence Basics for medical technology 20. December 2022
  • Testing for cytotoxicity: The “well-established” EN ISO 10993-5 21. October 2022
  • Cleanliness of medical devices 28. September 2022
  • eIFU-Pflicht-seleon Electronic instructions for use – The hidden duty of MDR 17. August 2022

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Fabiola Hartung-Linz
SALES DIRECTOR CONSULTING
Tel.: +49 7131 2774 - 40
Email: regulatoryaffairs@seleon.com
seleon GmbH
Any Questions? +49 7131 2774-0
seleon gmbh
Im Zukunftspark 9
74076 Heilbronn

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