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 team behind the first disease-agnostic Class IIb SaMD.
Topics covered include:
- 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
The key learning objectives from this webinar will be to:
- 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.