Understanding AI, ML and more in Software as Medical Device (SaMD) with a GMP ISO Expert

Whitepaper | June, 2022

The rising digitization of practically all aspects of care delivery is one of the most important advances in healthcare today. Digitization has the potential to impact every aspect of medical device technology, with far-reaching implications for patients, providers, payers, and regulators.

Also, digital health has the potential to make the delivery of healthcare more accessible, convenient and cost-effective. Software as a Medical Device (SaMD), a type of digital health software technology, has the potential to offer tremendous benefits to the healthcare system such as assisting in diagnosis, screening, monitoring and prediction of a disease enabling a professional to take preventive measures at the right time. It also presents new challenges and unfamiliar territory in regulating software that can have frequent updates.

However, to identify and track SaMD throughout its life, regulators and industry must agree on a globally implemented device identification and coding standard. They are distinct from traditional medical devices, which can be physically labelled with a Unique Device Identifier.

In this video whitepaper, we will discuss the following topics:

  • What is Software as Medical Device
  • History of Software as Medical Device
  • High-level SaMD components
  • Artificial Intelligence/Machine Learning in Software as Medical Device
  • And more

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