Prem Pandey
Head of EU MDR Compliance
Prem is a PMCF Clinical and Regulatory Services Manager at Cetas Healthcare and has several years of experience in clinical and regulatory domain of Medical Technology and consulting. He has extensive experience in several device spaces including Hip & Knee implant Medical Suction equipment's, skin stapler, Guidewire, General Surgical Devices, sodium hyaluronate (biomedical device), Topical wound Dressing device & Imaging device. He has experience in planning and execution of clinical and regulatory Document for assigned therapeutic area and projects including systematic literature reviews, plans (CEPs), clinical evaluation reports (CERs), post-market clinical reports (PMCRs), STED, GSPR, Risk analysis plan /report and Usability documents.Perform literature searches (generating literature search protocols, reviewing/appraising results obtained, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation.Providing CER SME support as needed by CER teams during development of new CERs and remediation of existing CERs.

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