About
Systematic literature reviews are required by regulatory agencies prove the safety and performance of medical devices. Separate reviews must be conducted at every stage of the device life cycle, including pre-market research, development, device certification, and post-market surveillance.

80% of Class IIa and Class IIb devices and almost 60% of Class III
devices fail EU MDR due to non-conformant literature reviews. The main
reasons fall into 3 types of issues:
1. Data issues - Volume, variety and velocity of data needed for reviews
2. Absence of skills - Lack of expertise in regulatory affairs and data
science
3. Ambiguity - Ambiguity around new device types, e.g., connected devices

Please join Jacqueline van Druten, Clinical & Regulatory Affairs
Director for CLIN-r+, as she reviews common mistakes made in the
literature review process and the steps needed to avoid them.
Presenter
1718623302-af84398a747339e6
Jacqueline van Druten
Clinical & Regulatory Affairs Director, CLIN-r+
Jacqueline van Druten (MICR.CIM.RD) is a medical professional with extensive experience in Clinical Regulatory Affairs. With a passion for MedTech, Jacqueline has been a driving force building CLIN-r+ EU MDR submissions automation and fast track Clinical Development Strategy workflow for EU MDR submissions for manufacturers. Her expertise is backed by 20 years of hands-on experience in healthcare research and medical innovations.

As a contributor and lead in Research, Regulatory and Clinical Affairs at various multi-national medical organizations, Jacqueline has been instrumental in supporting the translation of medical interventions into measurable patient outcome data. Enabling healthcare innovations obtain regulatory clearance, market access and product differentiation to meet their investment promise. Her career and team contributions have a proven track record of success in obtaining and maintaining EU MDR CE marking in various product classes, demonstrating their deep understanding of obtaining a successful innovation profile for commercial, clinical benefit and regulatory compliance.
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