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Regulatory Affairs Blog

Category: Regulatory Affairs

seleon GmbH > Regulatory Affairs
28 Apr, 2023
Regulatory Affairs, Regulatory Affairs

The translation dilemma – Intended use vs. intended purpose

by Hinsija Schilling
13 Mar, 2023
Regulatory Affairs, Regulatory Affairs

Technical documentation – international concepts for demonstrating safety and performance

by Hinsija Schilling
03 Mar, 2023
Regulatory Affairs

The IVDR: One year after its entry into force

by Hinsija Schilling
03 Mar, 2023
Regulatory Affairs

The MDR (EU) 2017/745 and its 2023 deadline amendments

by Hinsija Schilling
03 Feb, 2023
Clinical Affairs, Regulatory Affairs

Periodic Safety Update Report after 2 years MDR

by Hinsija Schilling
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
1 2 3 … 7

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Newest Articles

  • seleon GmbH: 25 years of experience in the field of medical technology 4. May 2023
  • The translation dilemma – Intended use vs. intended purpose 28. April 2023
  • Technical documentation – international concepts for demonstrating safety and performance 13. March 2023
  • The IVDR: One year after its entry into force 3. March 2023

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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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