RAPS Workshop: Software as a Medical Device (SAMD) June 2024

Navigating the regulatory expectations for software-based products is particularly challenging and requires a specific 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 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.

This interactive workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global SaMD expectations. Technical staff will get a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of gaining green lights from regulators and better strategize their development program.

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Registration Fees & Deadlines

Learning Objectives

• Thoroughly understand international regulatory expectations for Software as a Medical Device (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?

This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global SaMD expectations. Technical staff will gain a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of successful submissions and help establish trust with customers who have concerns about risks related to medical devices on their networks.

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
CEO, MedSec

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.

Pat Baird
Senior Regulatory Specialist, Philips

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.

Food and Drug Administration, CDRH
RAPS Invitation pending as of March 26, 2024

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