Software as a Medical Device

12.0
RAC Credits
In-PersonIn-Person
Thursday, 13 October 2022 (9:00 AM) - Friday, 14 October 2022 (5:00 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.

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

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.

Ian Marcus Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence (DHCoE) at FDA




Registration Fees & Deadlines

Registration fee includes:

  • Breakfast and lunch each day
  • Continuous beverage break service
  • Complimentary WiFi
  • Complimentary Parking for Local Attendees

 

Members

Non-Members

Early Bird (by 13 September 2022)

$1,100

$1,300

Regular (by 10 October 2022)

$1,300

$1,525


Location

RAPS Headquarters:

5635 Fishers Ln
Terrace Level

Rockville, MD 20852


Hotel


EVEN Hotel Rockville - Washington DC Area, an IHG Hotel
1775 Rockville Pike
Rockville, MD 20852

Reservations:

A limited number of rooms is available at the rate of $119.00 + tax.

Book online at Even Hotel Rockville or by phone: 855.879.3836

Group Code: AMD

Reservations must be made no later than 26 September 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, 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 Thursday, 29 September 2022 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 29 September 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.

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.

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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