Rok Hrovatin, Chief Compliance Officer, talks about Software as a Medical Device (SaMD), the classification of medical software and about the Rule 11 of Annex VIII of the MDR.
We invite you to listen to the interview, and find the answers to questions such as;

- How is medical software classified?
- What are the key points about software as a medical device in the new European Medical Device Regulation?
- How has classification of software as a medical device changed under the MDR?
- What are some examples of software as a medical device that would be classified as Class I, Class IIa, Class IIb, and Class III?
- What do manufacturers need to keep in mind for software as a medical device when it comes to cybersecurity and security of patient data?
- What standards are related to software as a medical device?

If you have any questions about the content of this video or if you are interested in how you can reduce the time to market of your medical device, please contact us at info@arrowfast.tech. The ArrowFast team of experts will be happy to help you.

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