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Regulatory Affairs Blog

Category: Lifecycle Processes

seleon GmbH > Lifecycle Processes
alarm kakophonie
24 Feb, 2022
Lifecycle Processes

DIN EN 60601-1-8:2021 – The End Of The Alarm Cacophony?

by seleonadmin
Lampe - Strahlung
20 Dec, 2021
Lifecycle Processes

No dirt can fight off this radiation!

by seleon
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
Zielscheibe - Bullseye - Pfeil
08 Jun, 2021
Lifecycle Processes, Regulatory Affairs

A restful hand and restful translation

by seleon
Surfen - Welle
25 May, 2021
Lifecycle Processes, Regulatory Affairs

Riding the wave means being successful

by seleon
Wachstum - Pflanze
29 Apr, 2021
Lifecycle Processes, Regulatory Affairs

When the certification process drags on…

by seleon
Labyrinth - Regenschirm
19 Mar, 2021
Clinical Affairs, Health Software, Lifecycle Processes, Regulatory Affairs

Standardization, harmonization, MDR

by seleon
Lachs - Fleisch - Gabel
10 Feb, 2021
Lifecycle Processes, Regulatory Affairs

The English Way – aka “UK MDR 2002

by seleon
1 2 3 … 5

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Newest Articles

  • Technical documentation – international concepts for demonstrating safety and performance 13. March 2023
  • The IVDR: One year after its entry into force 3. March 2023
  • The MDR (EU) 2017/745 and its 2023 deadline amendments 3. March 2023
  • Periodic Safety Update Report after 2 years MDR 3. February 2023

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Fabiola Hartung-Linz
SALES DIRECTOR CONSULTING
Tel.: +49 7131 2774 - 40
Email: regulatoryaffairs@seleon.com
seleon GmbH
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