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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Navigating the regulatory expectations for software-based products is particularly challenging and requires a different approach. 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 categorized as an SaMD and how to correctly classify it under global requirements. Given that assessing risk for software is more challenging, attendees will use case studies to help them complete required evaluations.
5 January 2023 — 23 January 2023: Early Bird $825 Member | $970 Nonmember
24 January 2023 — 21 February 2023: Regular $970 Member | $1150 Nonmember
Anyone wanting to learn more about Software and Medical Devices.
Pat Baird oversees global software standards 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 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 of 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.
Michelle Jump is the Global Regulatory Advisor, Medical Device Cybersecurity at MedSec, where she provides strategic leadership, training, and advisory services to the medical-device industry around cybersecurity compliance, global regulations, standards, product security program development, and security risk management.
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.
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