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 &
5 January 2023 — 14 May 2023: Early Bird $825 Member | $970 Nonmember
15 May 2023 — 14 June 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.
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 workshop: https://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.