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MedTech Chats: Software as a Medical Device

The concept of software as a medical device as it appears in Rule 11 of Annex VIII of the EU MDR.

MedTech Chats: Software as a Medical Device

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.

Igor Rogelj from ArrowFast speaks to Rok Hrovatin, Chief Compliance Officer at ArrowFast, about software as a medical device as it is described in the new EU Medical Device Regulation.

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?

We invite you to press play below & upgrade your knowledge about Software as a Medical Device.

 

Learn about the ISO 14971:2019 standard that also relates to software as a medical device.

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ArrowFast Team

ArrowFast Team

ArrowFast Team - A group of Medical Device Engineering Specialists

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