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Regulatory Affairs Blog

Category: Health Software

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

The Way out of the MDR standards jungle

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

Standardization, harmonization, MDR

by seleon
Essen - Fitness - Sandwich
08 Feb, 2021
Clinical Affairs, Health Software, Lifecycle Processes, Regulatory Affairs

fasting – with a focus on the MDR

by seleon
Laptop - Schwanger - Video - Tutorial
18 Sep, 2020
Clinical Affairs, Health Software

Without DiGA you can’t…

by seleon
Schreibmaschine - Laptop
16 Jun, 2020
Clinical Affairs, Health Software

Data of established medical devices in further use

by seleon
Fußballplatz - Elfmeter - Fußball
14 May, 2020
Clinical Affairs, Health Software

Accurate: Clinical evaluation of medical device software

by seleon
Muskeln - Man
27 Mar, 2020
Health Software

Cybersecurity is patient protection: new guide published

by seleon
Weihnachtsman - Schnee
20 Dec, 2019
Clinical Affairs, Health Software, Lifecycle Processes, Regulatory Affairs

Corrigendum II MDR

by seleon
Frauen - Lesen
05 Dec, 2019
Clinical Affairs, Health Software, Lifecycle Processes, Regulatory Affairs

MEDDEV is going, MDCG is coming – an update of the guidance documents

by seleon
Taschenmesser - Rot
14 Feb, 2019
Health Software, Lifecycle Processes

Projects, documents and requirements in medical technology: field-tested software

by seleon
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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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