Arun Periyasamy Email and Phone Number

Post market Survelience Plan (PMSP), Support for Clinical Evaluation Report (CER), Periodic Safety Update Report (PSUR), Post-Market Clinical Follow up Plan (PMCF Plan), Summary of safety and clinical performance (SSCP) Health canada summary report (HCSR), Post Market Survelince report (PMSR) Product performace analysis (PPA),Prod for various medical devices as per EU Medical Device Regulations.Having experience in quality review of class I, II, and III medical devices reports.Involved in Quality assessment of clinical documents as per the EU MDR, MEDDEV and MDCG Guidelines.Experienced in clinical literature search and summarization activities.Detail-oriented, highly organized, and able to prioritize and organize projects to meet deadlines. Strong verbal, written, and interpersonal communication skills with excellent judgment and problem-solving abilities. Proactive and action-oriented with strong technological aptitude.Demonstrated meticulous attention to detail while reviewing and preparing regulatory documents and submissions.Effectively resolved complex regulatory and quality issues by analyzing and synthesizing information from multiple sources and proposing innovative solutions.Acted as Defect Prevention Analyst (DPA) and good confidential Defect Finding, Defect Reporting,Implementing Defect Prevention techniques, Root Cause Analysis (RCA), Defect Trend and Management,conducting defect triage meeting.Assisted in collating, analyzing the quality related data, results, artifacts & predicting the trends, quality risks, project risks and provided solutions & mitigation plan.Responsible for driving defect free deliverables and involved in Metrics collection, Analyzing Metrics and Quality Trend, QA Process Improvements, Project Closure Meetings. Creating Knowledge.Knowledge on Global Medical device Regulation including but limited to: EU MDR, US FDA, Health Canada,etc.,

Developing, test, modify products,and equipment.Plan all financial aspects and engineering responsibilities related to medical equipment.Engineer safety alerts for medical devices. Record maintenance Training and demo for new joiners and customers Traveling with other region for machine service and salesERP maintenancetrainer