At this two-day virtual workshop, regulatory experts will review current and evolving regulatory requirements for Software as a Medical Device (SaMD) to navigate the challenging expectations for this category.
Navigating the regulatory expectations for software-based products is particularly challenging and requires a specific approach. Join industry experts and explore the current and evolving global regulatory requirements affecting SaMD. Our expert faculty will address both how to determine when software is categorized as a 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
Present until 18 February 2026: Early Bird $865.00 Member | $1,020 Nonmember
19 February 2026 – 19 March 2026,: Regular $1,020 Member | $1,200 Nonmember
Learning Objectives
- Thoroughly understand international regulatory expectations for SaMD, with particular focus on United States and European Union
- Understand the related considerations for working with SaMD such as cybersecurity, privacy, artificial intelligence, cloud issues, and more
- Know how to use the FDA Digital Health Policy Navigator and associated regulatory guidance documents to properly classify software products
- Be able to build more successful regulatory submissions
Who Should Attend?
- Regulatory and quality professionals
- Technical staff
- Organizational leaders
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Agenda
- Introduction to SaMD and Digital Health
- US Regulatory Guidance
- International Overview
- MDR Perspective for EU
- How to Think Like an FDA Reviewer
- Draft Guidance on Software and its Defects
- New Developments in Cloud Environments
- Cybersecurity, privacy and Interoperability Concerns
- Wearables Use Case and QS and Design Considerations
- Policy Navigator Program
- Supporting a Strategy that Supports Innovation
- Artificial Intelligence
- Regulatory Science Landscape
Speakers
Michelle Jump is the CEO, of MedSec, where she is responsible for providing strategic leadership, training, and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management.
Cancellations and Refunds
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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the 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
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.