Madhu Srinivas Murthy

Background

About Madhu Srinivas Murthy

A competent and consummate Professional Medical Writer with over 9+ years of experience in Medical and Technical Writing of Medical Implants, diagnostics, and Instruments with specialization in Clinical Evaluations; Performance Evaluations; Scientific Validations; Risk Management; and Literature review process. Also experienced in clinical study reports and regulatory premarket submission (510k drafting). Extensive experience working with Top Medical Device Manufacturers on Orthopedic Spine and Renal Medical Device products, processes, and deliverables. Authored and reviewed Spine and Renal portfolio Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), Post market Surveillance documents (PMSP and PMSR), and Post-Market Clinical Follow-up (PMCFP and PMCFER), Summary of Safety and Clinical Performance (SSCP) Patient & HCP versions, and State of the Art (SOA) Libraries. Responsible for defining critical Key Safety & Performance parameters and conducting Risk Benefit analysis for Medical Devices (Class I, Class IIa, Class IIb & Class to support compliance with EU Medical Device Directive (MDD) Essential Requirements (ERs) and Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPRs). Possess excellent communication, interpersonal skill, scientific leadership, analytical and problem solving skills with a strong focus on executing company strategy Proven track record in managing cross-functional projects and increasing product efficiency and effectiveness. Certified Six Sigma Green Belt. Skills: • Medical Device Knowledge • Regulatory Submissions and Compliance • MEDDEV REV 4, MDR, FDA, SaMD, IVDR, SOR /98-282, TGA Medical Device Regulations • Literature Screening and Appraisal • Quality Standards • Quality Reviews • Clinical Evaluations and Research • Technical and Medical Writing • Analytical and Critical Thinking • Excellent Communication • Training and Development • Attention to Details