Software as a Medical Device (April 2023)

RAC Credits
Tuesday, 18 April 2023 (9:00 AM) - Wednesday, 19 April 2023 (4:00 PM) Eastern Time (US & Canada)
5635 Fishers Ln
Rockville, Maryland, USA, 20852-1796

Finding your way through the regulations, standards, and interpretations applicable to health software – particularly software as a medical device (SaMD) – can be daunting as it requires a different approach from other medical devices.

In this two-day, in-person workshop, regulatory experts will explore the current and evolving global regulatory requirements affecting SaMD, how to determine when software is considered regulated as SaMD and how to determine the correct class/classifications under global requirements.

Attendees will learn how to address the numerous challenges in performing risk management/assessment for software by completing required evaluations using practical case studies.

Registration Fees & Deadlines

January 03, 2023 – March 17, 2023: Early Bird $1,135.00 Member | $1,340.00 Nonmember 
March 18, 2023 – April 18, 2023: Regular $1,340.00 Member | $1,570.00 Nonmember

Learning Level:

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.


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

Who Should Attend?

Anyone wanting to learn more about Software and Medical Devices.


Michelle Jump

Michelle Jump is the Vice President of Security Services, Medical Device Cybersecurity at 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

Pat Baird is a Senior Regulatory Specialist 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, the AAMI committee on agile software development, and the AAMI committee on the use of cloud services in medical devices. His current passion is related to artificial intelligence in healthcare; he is the convenor or co-chair of several AI committees including AAMI and CTA and is active on ISO/IEC standards as well as the MITA trade association. He also is an industry representative on the IMDRF AI committee.

FDA Speakers Invited

Registration fee includes:

  • Breakfast and lunch each day
  • Continuous beverage break service
  • Complimentary Wi-Fi
  • Complimentary parking


RAPS Headquarters

5635 Fishers Ln
Terrace Level
Rockville, MD 20852


Parking will be free at RAPS HQ with a validated ticket. Please make sure to bring your parking ticket to registration to validate parking. Overnight parking is not allowed.


Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr
1750 Rockville Pike
Rockville, Maryland, 20852-1699, USA
Telephone: (301) 468-1100
Hotel Website
Distance to RAPS HQ: .8 miles
Directions to RAPS HQ

EVEN Hotel Rockville
1775 Rockville Pike
Rockville, MD 20852
Telephone: (301) 881-3836
Hotel Website
Distance to RAPS HQ: .7 miles
Directions to RAPS HQ

Be Well Policy

RAPS has initiated a Be Well policy, with consent required during the registration process. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while onsite at RAPS HQ, you will reconsider your participation at the event.

To ensure your personal safety and comfort during this event, RAPS is committed to robust and transparent communications during the event. We encourage all participants to monitor RAPS social media channels and download the conference app to their mobile devices to receive up-to-the-minute updates.

Cancellations and Refunds

All cancellation requests must be submitted in writing to Cancellation requests received by March 17, 2023 will receive a full refund minus a 20% administrative fee. Cancellation requests received after March 17, 2023 will be non-refundable, except in cases of documented medical emergencies. RAPS is unable to accept cancellations by phone. Refunds will not be issued for no-shows.


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 with the event title, name of the original registrant and the contact information for the new attendee.

Meeting Cancellation: RAPS reserves the right to cancel any program at its sole discretion, whereupon all registration fees will be refunded within seven business days. RAPS is not responsible for any costs incurred due to a cancellation.

Photography Policy

By registering for this RAPS Event, you grant full permission to RAPS to capture, store, use, and/or reproduce your image or likeness, photograph, voice, and comments, and use such content in any and all media or forms by RAPS or third parties without compensation or notice, including for promotional or advertising purposes. You also waive any right to royalties or other compensation arising from or related to the use of the images, recordings, or materials. By registering, you release, defend, indemnify and hold harmless RAPS from and against any claims, damages or liability arising from or related to the use of the images, recordings or materials, including but not limited to claims of defamation, invasion of privacy, or rights of publicity or copyright infringement, or any misuse, distortion, blurring, alteration, optical illusion or use in composite form that may occur or be produced in taking, processing, reduction or production of the finished product, its publication or distribution.


Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email  


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