Software as a Medical Device

12.0
RAC Credits
In-Person In-Person
Wednesday, 29 June 2022 (9:00 AM) - Thursday, 30 June 2022 (5:00 PM)
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.

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 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.

Since performing risk management/assessment for software is generally more challenging, attendees will work through completing required evaluations using practical case studies.


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 and how to classify different SaMD products
  • Creating a strategy for software as a medical device
  • International overview of upcoming SaMD issues

June 29, 2022 12:00 pm – 1:30 pm Conversations that Matter: Ask the Experts (boxed lunch provided)


Just added! Workshop participants are invited to attend an Ask the Experts lunch as a complimentary part of the event experience. The exclusive lunch is a unique opportunity to have one-on-one conversations with regulatory experts in a relaxed environment. Register for a workshop and take advantage of this additional networking opportunity!


Instructors:

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 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.

Registration Fees & Deadlines

Registration fee includes:

  • Breakfast and lunch each day
  • Continuous beverage break service
  • Complimentary evening Kickback® of hot food, soft drinks, beer, wine, & mixed drinks
  • Complimentary WiFi

 

Members

Non-Members

Early Bird (by 21 May 2022)

$1,100

$1,300

Regular (by 21 June 2022)

$1,300

$1,525

Location

Drury Plaza Hotel St. Paul Downtown

175 10th Street E.

St. Paul, Minnesota 55101

Reservations:

A limited number of rooms is available at the rate of $135.00 + tax.

Book online at www.druryhotels.com or by phone: + 1 800 325 0720

Group Code: 2451470

Reservations must be made no later than 31 May 2022.

Vaccination Requirement

RAPS will require proof of COVID-19 vaccination or proof of a negative PCR test taken within 24 hours of arrival in order to attend. Unvaccinated individuals or those unable to provide proof of vaccination or a negative PCR test will not be permitted to attend.

RAPS will continue to monitor any new developments and evaluate what is needed to ensure you are comfortable and we meet safely. We will keep all participants updated as we get closer to the event.

Be Well Policy

Participants must follow RAPS’ Be Well policy, which requires consent during registration by all attendees as a condition of on-site participation. This includes the stipulation that if you feel sick or are experiencing COVID-like symptoms prior to traveling or while on site in St. Paul, you will reconsider your participation at the event. To help ensure your personal safety and comfort, RAPS is committed to robust and transparent communications. We encourage all participants to monitor RAPS’ social media channels to receive the latest updates.

Cancellations and Refunds

All cancellation requests must be submitted in writing to support@raps.orgCancellation requests received by Friday, 27 May 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 27 May 2022 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.

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.

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.

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  

 

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