Senior Manager, Regulatory and Quality
NAMSA
Over 15 years experience in IVD research, development, manufacturing and quality management. Served as Quality Manager ensuring compliance with legislation, managing quality documentation, risk assessment, risk management and audits. Expert in reviewing technical files and guiding IVD sponsors for IVDR compliance. Creating Performance Evaluation Plans (PEP) for IVD devices to be used as part of technical file submissions for IVDR compliance and to carry out performance evaluation. This encompassed creating Analytical performance reports (APRs) for IVD devices. Significant experience in gap analysis reviews of analytical performance data and determination of the data is to the latest guidelines for performance, acceptable to IVDR standards and advise on solutions. Clinical performance report creation including review of clinical performance studies and literature to determine the needs of devices and any gaps for IVDR compliance or US submissions. Scientific Validity report creation with search and review of scientific literature for analyte link to pathological or physiological conditions as stated in the IVDR. Post market surveillance reviews with creation of Post market surveillance reports (PMSRs) or periodic safety update reports (PSURs). Furthermore, being technical lead in large project teams with managing personnel and clients, and carrying out reviews of work to ensure that reports generated were high quality and met the IVDR standards.
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Don’t Get Orphaned: How To Be Novel in the IVDR Environment
Tuesday, May 7, 2024
16:45 – 17:45 CEST