Software as a Medical Device

12.0
RAC Credits
Virtual Programs Virtual Programs
Tuesday, 25 January 2022 (9:00 AM) - Wednesday, 26 January 2022 (4:00 PM) Eastern Time (US & Canada)

Finding your way through the regulations, standards, and interpretations applicable to health software – particularly software as a medical device (SaMD) – can be daunting.

In this two-day 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 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.

Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. 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 considered regulated as SaMD and how to determine correct class/classifications under global requirements. Since performing risk management/assessment for software is generally more challenging, attendees will work through completing required evaluations using practical case studies.

Please note that there will be an FDA speaker present at this workshop. The name of the speaker will be announced closer to the event.

Registration Fees & Deadlines

Until 25 December 2021: $825 Member | $970 Nonmember
After 26 December 2021: $970 Member | $1,150 Nonmember


Agenda

Day 1

  • Digital health overview and the development of SaMD
  • The European perspective on SaMD under the EU MDR
  • The cybersecurity, privacy and interoperability issues with SaMD and digital health
  • Artificial intelligence
  • New developments in cloud environments
  • 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 a digital health
  • 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
*Agenda is subject to change.

Instructors

Patricia Cash

Michelle Jump is the Global Regulatory Advisor, 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 the head of global software standards at 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 in 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.

Cancellation Policy

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. 

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

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

For additional hands-on support, you can 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:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org 

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