ISWARYA MURUGADASS

Company Overview: MDR Compliance Program DePuy Synthes Switzerland – On Deputation: HCL & Offshore PDE

• Implemented remediation plan for MDR technical files of Orthopedic Trauma CMF, resulting in seamless transition to MDR compliance
• Collaborated with cross-functional teams to implement a remediation plan, resulting in a seamless transition to MDR compliance
• Undertook extensive documentation review, performed gap analysis, and updated technical files
• Interacting with client to understand the requirements and providing training to offshore counterpart for task completion
• Conducted comprehensive analysis and verification of Regulatory documents, aligning with EU MDR – Regulation – EU 2017/745 guidelines: identified and rectified compliance gaps, mitigating potential risks and ensuring seamless market access for company products
• Created/Updated the Verification & Validation Summary report, Standard Evaluation – SEV, Biocompatibility, and List of Applied Standards, meeting MDR requirements
• Reviewed/updated Risk Documents – Design & Clinical Risk Management & Risk Management Summary report in line with Surgical Technique Guide – STG, Labels, and Labelling consistency documents
• Created/updated the Trace matrix for Class I, Class II, and Class III Orthopaedic Implants
• Created documents for new MDR requirements like PIL – Patient Information Leaflets, Implant cards, and General Safety & Performance documents
• Reviewed Instruction for use
• Interacted with internal customers to understand business needs and translate into requirements and project scope.
• Enhanced product performance by streamlining design processes and implementing automation tool.

• Remediated DHF files like Plan document, DMR matrix, and Sub System documents, and five major control documents – Design input, Design Output, Design V&V, Risk management, and Trace matrix for Orthopedic Implants
• Created Drawing Verification Review reports and Labeling Verification Report
• Verification of labels that meets the user needs & regulatory requirements by comparing with Subsystem & ISO 15223
• Revised documents in Client PLM QCBD
• Modified the Design History file for orthopedic implants to comply with medical device standards

• Remediate and maintain the documents in line with MDD requirements – 93/42/EEC
• Creation/Updating of Bio Safety Evaluation Form – F'S738 referring to chemical assessment plan/report and by analyzing the approved raw material and packaging material – Biocompatible
• Creation of Manufacturing Process Information – F'S785 for Implants, Instruments and Graphic Cases
• Worked in Client PLM tools – Windchill, Agile, JDE, and Tungsten
• Interacted with Client to understand requirements and provide status updates
• Updated Shared service documents like Packaging, Sterility, and labels in Trace matrix

• Achieved the development of methods, and procedures to determine product quality
• ISO 13485, ISO 9001 and CE certification surveillance audit
• Various products including Membrane oxygenate, Arterial blood filter, Arterial Bubble traps, Custom pack, Chest Drainage system, Cardioplegia delivery system – CPDS, and myocardial protection system – MPS
• Decreased the probability of product rework by 95% through performing quality assurance inspections
• Verified raw materials against quality standards and adherence to specifications
• Conducted internal audits and spot inspections of materials
• Revised Technical files for Class IIA and Is medical devices for Surveillance audit
• Monitored product performance to ensure efficient and problem-free operations
• Ensured timely delivery of high-quality products through effective coordination with cross-functional teams.