In this two-day, virtual workshop, to be held on 16 November and 18 November 2026, 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.
Technical teams will learn how to effectively translate regulatory requirements into practical design and development processes. Organizational leaders will gain strategic insights that will improve their chances of securing regulatory approval and help them better align their development programs with industry standards.
Learning Objectives
Upon the completion of the program, you will be able to:
- Understand international regulatory expectations for SaMD, with particular focus on US and European Union.
- Comprehend the related considerations for working with SaMD such as cybersecurity, privacy, artificial intelligence, cloud issues, and more.
- Use the FDA Digital Health Policy Navigator and associated regulatory guidance documents to properly classify software products.
- Build more successful regulatory submissions.
- Identify the key standards and guidance documents applicable to Software as a Medical Device (SaMD) and understand how they support regulatory compliance throughout the product lifecycle.
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 on Digital Health and Software
- Summary of International SaMD Regulations
- European Union (EU) Regulatory Framework and Guidance for Medical Device Software (MDSW), including SaMD
- Qualification and Classification – Is It a Medical Device?
- Cybersecurity Considerations for SaMD
- QS and Design Considerations
- Standards for Medical Device Software (MDSW), including SaMD
- Artificial Intelligence (AI) including Machine Learning (ML): Guidance, Standards, and Concepts
- Post-market Support for SaMD
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 [email protected]. 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 [email protected] 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 [email protected].
Speakers
Michelle Jump
