Nasar Ansari

Clinical Evaluation and Medical Writing professional with 6+ years of experience authoring and maintaining Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Clinical Follow-up (PMCF) Plans and Reports, Summary of Safety and Clinical Performance (SSCP), PMS Reports (PMSR), and other EU MDR clinical documentation for Class I–III medical devices. Extensive experience supporting EU MDR (2017/745) compliance through systematic literature reviews, State of the Art (SOTA) analyses, clinical data appraisal, risk-benefit assessments, and clinical evidence generation strategies in accordance with MEDDEV 2.7/1 Rev.4, MDCG guidance documents, ISO 14155, and ISO 13485 principles. Proven ability to collaborate with Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, R&D, and Marketing teams to develop robust clinical evidence packages supporting product registrations, renewals, and lifecycle management activities.

Experienced across orthopedic, endosurgical, cardiovascular, and implantable medical devices with strong expertise in scientific writing, clinical data interpretation, and regulatory submission support.

Assistant Manager – Regulatory Affairs - Meril Life Sciences Pvt. Ltd.

(2019-10)

Major Therapy Areas & Devices: Orthopedic: Total Knee & Hip Replacement, Trauma Systems, Robotic TKA; Endosurgery: Absorbable/Non-absorbable Sutures, Meshes, Trocars, Copper IUDs, Surgical staplers; Other: Liquid Embolics, IUDs, Catheters, Drug-Eluting Stents

• Author and maintain Clinical Evaluation Reports (CERs) in compliance with EU MDR (2017/745), MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents for Class I–III medical devices.
• Develop and update Clinical Evaluation Plans (CEPs), Summary of Safety and Clinical Performance (SSCP), PMS Reports (PMSR), and other clinical evaluation documentation supporting global regulatory submissions and product lifecycle management.
• Prepare and review PMCF Plans, PMCF Evaluation Reports, and PMCF-related clinical documentation to support ongoing demonstration of device safety, clinical performance, and benefit-risk acceptability.
• Design and execute comprehensive literature search strategies and systematic literature reviews using PubMed, Embase, and scientific databases to identify and evaluate relevant clinical evidence.
• Conduct clinical data appraisal, evidence weighting, and scientific analysis of clinical investigations, post-market surveillance data, risk management documentation, and performance testing reports.
• Perform State of the Art (SOTA) analyses and clinical evidence gap assessments to support clinical evaluation strategies and PMCF activities.
• Collaborate with Clinical Research, Regulatory Affairs, Quality Assurance, R&D, Medical Affairs, and Marketing teams to collect, analyze, and interpret clinical evidence required for CER development and regulatory submissions.
• Support preparation and review of clinical investigation documentation, study protocols, scientific reports, and regulatory submissions in accordance with EU MDR and ISO 14155 requirements.
• Ensure consistency between Clinical Evaluation, Risk Management, Post-Market Surveillance, and Technical Documentation throughout the product lifecycle.
• Participate in cross-functional reviews and Notified Body query responses to support successful MDR certification and maintenance activities.
• Contribute to continuous improvement of clinical writing processes, templates, and internal procedures to enhance efficiency, quality, and regulatory compliance.
• Monitor evolving EU MDR regulations, MDCG guidance documents, and industry best practices to ensure ongoing compliance and incorporation into clinical documentation.

M.Sc. - Clinical Research - Institute of Clinical Research India (ICRI), Mumbai (2019)

B.Sc. - Biochemistry - Mithibai College, Mumbai (2017)