Regulating Digital Health - Demystifying SaMD and its impact on MedTech
June
27

Regulating Digital Health - Demystifying SaMD and its impact on MedTech

 June 27, 2023 

Online


Arena International is a global B2B events company that goes beyond the traditional event experience to deliver enriching learning and networking opportunities .Don’t miss this opportunity to join Rudolf Wagner, who leads Huma’s Quality Assurance & Regulatory Affairs, alongside Alex Gilbert, Vice President of MedTech, for an insightful discussion on how regulated frameworks for Software as a Medical Device can contribute to the development of distinctive companion apps. This session promises to provide valuable insights from the topics Overview of Regulatory Framework, Regulatory certification benefits – re-assurance, patient safety, data safeguards, appropriate flagging, Regulated Digital Health – opportunities for MedTech, The value of building better patient and clinician engagement, How to establish novel opportunities for revenue and reimbursement.

Objectives:

  • Understand the regulatory framework for Software as a Medical Device (SaMD)
  • Recognize the benefits of obtaining regulatory certification for SaMD
  • Identify the opportunities for MedTech in regulated digital health
  • Learn how to build better patient and clinician engagement and establish novel opportunities for
  • revenue and reimbursement.


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