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Securing medical devices and documents for regulatory submissions from cyberattacks is challenging. Many medical device companies struggle to retrofit their security programs to address hardening, vulnerability management, and global- incident response.
Health authorities spanning the US, Australia, Canada, and Japan, have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes expectations for post-market expectations.
This interactive, in-person workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity.
Technical staff will get a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of gaining green lights from regulators while also teaching them how to establish trust with customers concerned about risk related to medical devices on their networks.
January 18, 2023 – March 20, 2023: $1135 Member | $1340 Nonmember
March 21, 2023 – April 20, 2023: $1340 Member | $1570 Nonmember
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations. Technical staff will gain a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of successful submissions and help establish trust with customers who have concerns about risks related to medical devices on their networks.
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.
Matthew Hazelett - INVITED
Matthew Hazelett is a Cybersecurity Policy Analyst, Food and Drug Administration Center for Devices and Radiological Health Office of Product Evaluation and Quality Clinical and Scientific Policy Staff at the FDA.
Hazelett started at the FDA as a biomedical engineer within the Implantable Electrophysiology Devices Branch at the Center for Devices and Radiological Health (CDRH). His review areas include pacemakers, defibrillators, leads, and supporting devices, such as programmers and home monitors. Since starting at FDA, Hazelett developed a review focus in cybersecurity, participates in cybersecurity guidance development, and supports cybersecurity vulnerability assessments and reviews across CDRH. He became the cybersecurity policy analyst in FDA’s Office of Product Evaluation and Quality a year ago, focusing on cybersecurity policy development and implementation. Hazelett also has worked for a medical device research and development company as a test engineer and test manager overseeing device verification and validation testing.
Linda Ricci - INVITED
Linda Ricci is the Director, Division of All Hazard Response, Science and Strategic Partnerships at the FDA. Ricci began her career developing AI solutions in the defense industry before moving to the medical-device field as a software engineer. She helped to develop several diagnostic cardiology devices and has participated in all phases of product life cycle development. Ricci moved to the FDA in 2005, and has held several roles including scientific reviewer and branch chief within the Division of Cardiovascular Devices and Associate Director for Digital Health within the Office of Device Evaluation. Ricci is the Director for the Division of All Hazard Response, Science and Strategic Partnerships. This position involved leading teams focused on medical-device cybersecurity, standards and conformity assessment, women’s health, pediatric and special populations, patient science and engagement, partnerships and regulatory science, and emergency response including COVID-related device shortages. She has degrees in electrical engineering, medical engineering, and public health.
RAPS Headquarters
5635 Fishers LnTerrace Level Rockville, MD 20852
Parking
Parking at RAPS HQ is free with a validated ticket. Please make sure to bring your parking ticket to registration for validation. 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 Friday, 17 March 2023 will receive a full refund minus a 20% administrative fee. Cancellation requests received after 17 March 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.
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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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Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.