Christine LambertSenior Clinical Research Scientist, Fisher & Paykel Healthcare, NZ
Christine Lambert (MPH) earned a Bachelor of Health Science (Hons) in child nutrition policy, and Master of Public Health in infectious disease epidemiology, both from the University of Auckland. She is a Senior Clinical Research Scientist at F&P, a New Zealand-based company that designs, manufactures, and distributes medical devices, including those that deliver PAP therapy for the management of respiratory conditions such as OSA. Ms Lambert has more than nine years of combined experience in health promotion, medical services, and clinical research. She is involved in evaluating product safety, efficacy, usability, and regulatory compliance at F&P, as well as supporting product development, risk management, marketing initiatives, clinical relationships, and patient education as part of her role.
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MedTech Studies and ISO Standards: Key Differences for CRAs and PMs
As medical device trials become more common, clinical teams must adapt to the distinct regulatory, operational, and risk management requirements that set them apart from drug studies. This session outlines what CRAs and PMs need to know when supporting device trials, from study conduct to monitoring and sponsor oversight. We’ll focus on the evolving ISO/DIS 14155 standard and how it compares to ICH GCP E6(R3).
Key topics include the shift from drug accountability to device tracking and usage, the importance of understanding participant interaction and usability risks, and the operational implications of complex devices. We’ll also cover device accountability, equipment return and destruction, and reporting device issues from a sponsor perspective.
The session will highlight how risk management, human factors, and monitoring documentation are integrated into device trials under the relevant standards. Whether you are transitioning from drug studies or looking to expand your knowledge of MedTech, this session provides clear, practical insights to support high-quality oversight of device investigations.
Key topics include the shift from drug accountability to device tracking and usage, the importance of understanding participant interaction and usability risks, and the operational implications of complex devices. We’ll also cover device accountability, equipment return and destruction, and reporting device issues from a sponsor perspective.
The session will highlight how risk management, human factors, and monitoring documentation are integrated into device trials under the relevant standards. Whether you are transitioning from drug studies or looking to expand your knowledge of MedTech, this session provides clear, practical insights to support high-quality oversight of device investigations.
