Sweeya Pisupati

Part of MedTech Real World Evidence team, responsible for EU MDR/EU IVDR evaluations for medical devices, medical software, and in vitro diagnostic devices. Mentor the team and support MDD-MDR and/or IVDD-IVDR transition, remediation and new product development activities, juggle with multiple clients. Contribute to the budget proposals for new projects, maintain resource management tracker, support the development of productivity metrics, coordinate with cross-functional teams

Critically review, analyze and appraise scientific literature to support Clinical Evaluation Reports (CER). Author literature reviews, summary of safety and clinical performance (SSCP), summarizing new risks, safety trends, potential off-label use, and current & emerging State-of-The-Art offerings. Initiated continuous improvement and collaboration activities within the team by successfully designing and implementing workflow management trackers, visually interactive automated dashboards, and newsletters.

Part of clinical evidence team ensuring a continued transition to EU MDR by performing gap analysis, developing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), literature search strategy, Post-Market Clinical Follow-up (PMCF) plans, and Summary of Safety and Clinical Performance (SSCP); compiling validation summaries that require clinical evidence as part of the Design History File and CE Technical File

Close association with Medical Safety Officers (MSO) for the generation of Medical Safety Assessments (MSA) for Approval of Product Release (APR) for Medical Devices, OTC drugs, Cosmetics, Consumer and baby products. Critical reviews of Health Hazard Evaluation (HHE) reports, Safety Summaries, Benefit-Risk Evaluation (BRE), Post-Market Safety (PMS), CAPA, toxicology, biocompatibility, Clinical studies, and preclinical studies. Expanded project scope to multiple geographical regions.

Identification, triage, registration, processing and QC of Individual Case Safety Reports (ICSRs) from Literature, clinical trials, MedWatch, and MHRA forms.

Developed study protocols for in vitro, in vivo, and ex vivo studies, performed statistical analysis and interpretation of results, peer-reviewed manuscripts and published research articles for Diabetes research.

Master of Pharmacy