Software as a Medical Device (SaMD) (Feb 2023)

12.0
RAC Credits
Virtual ProgramsVirtual Programs
Tuesday, 21 February 2023 (10:00 AM) - Wednesday, 22 February 2023 (4:00 PM) Eastern Time (US & Canada)

Navigating the regulatory expectations for software-based products is particularly challenging and requires a different approach. Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD). Our expert faculty will address both how to determine when software is categorized as an SaMD and how to correctly classify it under global requirements. Given that assessing risk for software is more challenging, attendees will use case studies to help them complete required evaluations.


REGISTRATION FEES & DEADLINES

5 January 2023 — 23 January 2023: Early Bird $825 Member | $970 Nonmember

24 January 2023 — 21 February 2023: Regular $970 Member | $1150 Nonmember


Learning Objectives

Day 1

  • Digital Health Overview & the Development of SaMD
  • SaMD from the MDR Perspective for EU
  • The Cybersecurity, Privacy, and Interoperability Issues with SaMD and Digital Health
  • Artificial Intelligence & SaMD
  • SaMD and Clouds Environments: New Developments
  • Wearables Use Case and QS and Design Considerations
  • Day 2

  • Review of the new FDA Draft Premarket Guidance for Software
  • Regulatory Oversight Framework in the US for SaMD & Digital Health: Guidance Overview
  • SaMD Use Case Studies: How do I classify that SaMD product?
  • Creating a Strategy for Software as a Medical Device
  • International Overview of upcoming SaMD issues

  • Audience Learning Level:

    N/A

    Who Should Attend?

    Anyone wanting to learn more about Software and Medical Devices.


    Instructors:

    Pat Baird

    Pat Baird

    Pat Baird oversees global software standards for Philips. Pat likes to think of his job as “Policy Engineering”—understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs the AdvaMed software committee and an AAMI committee on agile software development. His current passion is related to artificial intelligence in healthcare; he is the convenor or co-chair of several AI committees, including ISO/IEC TC215 AHG2 standards regarding AI in healthcare, MITA trade association, CTA trade association, Xavier University, World Health Organization, and is an industry representative on a newly formed IMDRF AI committee.

    Michelle Jump

    Michelle Jump

    Michelle Jump is the Global Regulatory Advisor, Medical Device Cybersecurity at MedSec, where she provides strategic leadership, training, and advisory services to the medical-device industry around cybersecurity compliance, global regulations, standards, product security program development, and security risk management.


    Cancellations

    RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

    All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

    To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.


    Proof of Attendance

    A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

     

    Questions

    For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

    For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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