Elavarasan Murugan

Experience

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  HCLTech

  Apr 2021 - Nov 2023

  Member of Technical Staff

  1. Involved in gap assessment and remediation to establish compliance for EU MDR 2017/745 and MDD 93/42/EEC regulations. 2. Identifying product specific and applicable harmonized standards such as ISO, BS EN etc.., for the products and ensuring that the product meets the compliance requirements. 3. Coordinating with CFT and working with product design, leads & Subject matter expert to resolve the gaps which are identified. 4. Identifying test methods and it's respective validation which supports DESIGN, PACKAGING & STABILITY.5. Actively involved in review of DHF documents, Design and Non-Design change with respective to DIET, DIA & DID. 6. Creation of product specification from DID/DCS to validate the trace matrix against the design specification of the product. 7. Protocol creation and executing test for the Product Shelf life, Lifetime of Use, Packaging Ship test, Packaging stability & System interoperability. 8. To Review GSPR, Tech file, Label, IFU, UDI for the Class l, Class II, Class III Medical Devices as per EU MDR regulation inorder to submission for STED. 9. Provided Knowledge Transfer about the activities to all 40 members in team 10. Collected BOM details via SAP for a product and collaboratively needs to review inorder to identify and analyse gap. 11. Acted as Defect Preventive Analyst for 40 members team on monthly basis. 12. Managed and performed LAB activities as organizer & Technician. Show less

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  Tata Elxsi

  Nov 2023 - now

  Regulatory Engineer

  Material Science | PFAS Material regulatory compliance