When Software is a Medical Device: What the Medical Device Regulations Say
You can enjoy full access to the most recent interview about the classification of medical software and the concept of software as a medical device (SaMD) as it appears in Rule 11 of Annex VIII of the EU Medical Device Regulation. You’ll hear answers to the following questions and so much more, including
How is medical software classified?
What are the key points about software as a medical device in the new European Medical Device Regulation?
What are some examples of software as a medical device that would be classified as Class I, Class IIa, Class IIb, and Class III?
Watch the complete video interview and find the answers to these questions, click here:
As medical device engineering specialists, ArrowFast helps MedTech startups from planning to developing their device. Our team of 200+ engineers makes sure that the development is done at a fixed budget and in line with medical device regulations. With 20+ years of experience, we serve partners across the globe.