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Home | [EN] Whitepaper Software as a Medical Device
6. August 2020

[EN] Whitepaper Software as a Medical Device

Nowadays, there is almost no active medical device without some interaction with software. Since the introduction of the European Medical Device Regulation 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), the industry talks about the impact and classification of Medical Device Software.

Our compliance expert Mike Seidenberg authored this paper, in collaboration with André Geiser.

Here is a quick peek at the content of this Whitepaper:

  • International Regulatory Requirements
  • Strategic Impact of Product Classification
  • Challenges for SaMD
  • SaMD & UDI

If you have questions, feedback, or just want input on compliance and regulatory topics, feel free to contact me:

 

Stefan Müller

MedTech & Compliance Lead

stefan.mueller@arcondis.com