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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
Day 1
Day 2
Anyone wanting to learn more about Software and Medical Devices.
Instructors:
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 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.
RAPS Headquarters
5635 Fishers LnTerrace 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
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.
All cancellation requests must be submitted in writing to support@raps.org. 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 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.
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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.