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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.

Software, when used as a medical device, has several challenges, including cybersecurity, clinical evaluation, scientific validity and clinical validation. The FDA is currently piloting a Software Pre-Certification Program to help the development of a future regulatory model for digital health technology such as SaMD.

Join us to learn:

  • History of Software as Medical Device (SaMD)
  • Recent developments and opportunities for SaMD
  • FDA’s Artificial Intelligence / Machine-based learning based SaMD Action Plan
  • FDA’s Digital Health Center of Excellence and pilot Software Pre-Certification Program
  • Concerns, recommendations, and Next Steps

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