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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.
Anyone wanting to learn more about Software and Medical Devices.
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.
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
Distance to RAPS HQ: .8 miles
Directions to RAPS HQ
EVEN Hotel Rockville
1775 Rockville Pike
Rockville, MD 20852
Telephone: (301) 881-3836
Distance to RAPS HQ: .7 miles
Directions to RAPS HQ
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