Angat Dhanjal

Senior Engineer @Tata Elxsi

Pune, IN

Ensured compliance of cardiovascular medical devices with EU MDR (2017/745) labeling requirements,including UDI (Unique Device Identification) implementation.Developed and reviewed labeling content in accordance with Annex I General Safety and PerformanceRequirements (GSPR).Managed multilingual labeling for EU markets, ensuring adherence to MEDDEV 2.7/1 and harmonizedstandards (e.g, EN ISO 15223-1, EN 1041).Prepared and maintained Technical Documentation (Annex II & for CE marking under EU MDR.Coordinated with Notified Bodies for label reviews and Clinical Evaluation Reports (CERs) related tocardiovascular devices.Ensured proper IFU (Instructions for Use) and patient implant cards for implantable cardiovasculardevices as per MDR ArticleImplemented labeling changes based on Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) data.Transitioned traditional labeling to electronic Instructions for Use (eIFU) in compliance with MDR Article10(11).Managed QR codes, barcodes, and RFID integration for enhanced device traceability.

Chhattisgarh Swami Vivekanand Technical University

Bachelor of Engineering - BE