Working as a QA/RA in Medical Devices with 4.10 years of experience in the Stability, Usability Engineering, risk management, Regulatory compliance and quality assurance in the medical devices including combination products.• Ensuring the product development activities and changing the existing product with MDR compliance.• Input data gathering for the medical devices with the help of Trackwise8 tool and TcU.• Performing gap assessment and remediation activities (plan and report) for the medical devices.• Standards Gap analysis and implementation.• Preparing the GSPR, STED as per EU MDR compliance during remediation phase.• Design History File (DHF) creation for medical devices in compliance with EU MDR.• To prepare Planning phase documents like Design & development plan, Intended use document, User requirements specification and Design phase documents like Design input requirements, Trace matrix, Design verification & validation plan.• To prepare Risk management related documents files like Risk management plan, Preliminary hazard analysis, System FMEA, User FMEA and Risk management report and ensure that all the design and process shortcomings are addressed with the standards, SOPs.• Ensuring that Design output specifications, Risk assessment documents, usability and V&V documentation, and other technical documentation meet design inputs.• Creating memos for the specific design inputs which requirements needed to be verified in the verification phase.• Adherence to MQMS (Medical Quality Management System) and Risk Management ISO 13485:2016, ISO 14971:2019.• Preparing customer metrics on the monthly basis.