Vaishnavi Subramanian

Working on Medical Device Regulatory MDR 2017/745

• EU MDR Packaging and Labeling compliance medical device packaging validation in compliance with ISO1 and ISO 11607-1, ISO 11607-2
• Standards: ISO 11607-1, ISO 11607-2, ISO 15223-1, ISO 14971, ISO 13485, ISO 20417,21 CFR Part 801
• Hands-on experience in drafting checklist and review of 3D CAD models for packaging Perform gap analysis of labels using EU MDR checklist
• Creation of label redlines with gaps identified, Creation of input document for labels using Labeling
• Attribute Master Plan (LAMP) tool
• Creation appropriate rationale, Implementation of final labels as per EU MDR compliance in client provided labeling system, Perform Peer review and Expert review of input documents to create defect free document and to improve quality of deliverables
• Assistance in Change management
• Medtronic EU MDR project is about performing EUMDR gap analysis and development of labels for in scope product families per EUMDR compliance for Medtronic
• Enhanced system reliability by conducting thorough root cause analyses and implementing corrective actions to prevent future issues.
• Defined engineering problems, collected data, established facts and drew conclusions to solve project issues.
• Maximized resource utilization with effective management of personnel, materials, and equipment for optimal project outcomes.

• Medical Device Regulatory MDR 2017/745 Packaging & Labeling activities.
• Experience in performing EU MDR gap analysis and remediation process for IVDR products position paper drafting, performance validation, verification of documents, process validation (E.g. Datamining for documents technical analysis and compliance with regulation for sterile & non-sterile, label design and using different label creation tools, PLM tools for release)
• Developed positive working relationships with stakeholders to effectively coordinate work activities.