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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.
Cybersecurity has proven to be a challenge to ensuring the security of medical devices and preparing documents for regulatory submissions. Many medical device companies struggle to retrofit security programs into quality systems not designed to address concerns such as hardening, vulnerability management and global incident response.
Health authorities in many regions, including the US, Australia, Canada, and Japan, have released new cybersecurity guidance documents and it’s essential for regulatory affairs professionals to understand their implications. In addition to premarket concerns, some of these guidance documents also include expectations for postmarket 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 expectations.
Technical staff will benefit from better understanding of how to translate regulatory expectations into concrete design and development activities. 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.
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 benefit from better understanding of how to translate regulatory expectations into concrete design and development activities. 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.
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, Cybersecurity Policy Analyst, Food and Drug Administration Center for Devices and Radiological Health Office of Product Evaluation and Quality Clinical and Scientific Policy Staff
Matthew Hazelett started at the US Food and Drug Administration (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, Director, Division of All Hazard Response, Science and Strategic Partnerships at FDA
Linda Ricci began her career developing artificial intelligence (AI) solutions in the defense industry before moving to the medical device industry 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 US Food and Drug Administration (FDA) in 2005 and has had 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 (DARSS). This role involves leading teams focused on medical device cybersecurity, standards and conformity assessment, health of women, pediatric and special populations, patient science and engagement, partnerships and regulatory science, and emergency response including device shortages due to COVID. She has degrees in Electrical Engineering, Medical Engineering, and Public Health.
Registration fee includes:
Early Bird 11 September 2022
Regular by 7 October 2022
5635 Fishers LnTerrace Level
Rockville, MD 20852
EVEN Hotel Rockville - Washington DC Area, an IHG Hotel
1775 Rockville Pike
Rockville, MD 20852
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: CYB
Reservations must be made no later than 26 September 2022.
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.
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