Regulating Digital Health - Demystifying SaMD and its impact on MedTech

Unlocking the full potential of MedTech: The crucial role of regulated Digital Health

27

June

  • 3PM London / 10AM New York
  • Free
  • Why attend?
  • Speakers
  • Contact Us

Why attend?

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.

Speakers

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Alex Gilbert
VP - Commercial Companion, MedTech, Huma London

Alex has worked within the Digital Health industry alongside healthcare, pharmaceutical, medical device
and tech organisations. He joined Huma as one of their first employees and leads their global MedTech
practice. Huma is Europe's fastest-growing health organisation, having raised over 250 Million in funding
to date whilst partnering with the likes of Smith & Nephew, Boston Scientific, Bayer, Stanford,
AstraZeneca and many more. His passion is the use of technology to empower and engage the patient to
take control of their care."

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Mani Shanmugham
Senior Director Quality & Regulatory, US & South America

Dr. Mani Shanmugham's qualifications include Ph.D in Human Factors Engineering from Mississippi State Univ, USA, Masters in Mechanical/Biomedical and Bachelors' in Mechanical/Materials Science Engineering. He was part of the original committee at AAMI and FDA HF and co-authored the following standards: IEC 62366-1 and 2 (Human Factors Engg Std) and AAMI TIR-50 (Contextual inquiry). His accomplishments include multiple medical device patents in infusion therapy, apheresis, and pediatric vascular devices, publications in peer-reviewed journals regarding Medical Device Alarms and Metacognition, Metamemory, and review board memberships at JMIR Journal.  Currently working as Director of QA/RA at Huma Therapeutics. Been in the medical device and pharmaceutical industries for the past 20+ years in R&D, Manufacturing, and QA/RA. Prior to Huma, worked at Boston Scientific, C.R.Bard, and Becton Dickinson at various capacities.

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