[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:
MedTech & Compliance Lead