Kameswer M

Dedicated product specialist with a strong background in ultrasound, offering extensive expertise in advanced imaging solutions. Passionate about utilizing technical knowledge to transition into QA/RA, ensuring the highest standards of safety and compliance for medical devices. Proficient in QMS, ISO 13485, ISO 14971, EU MDR, and US FDA regulations.

• ISO 13485, Familiarity with the International Standard for Quality Management Systems specific to medical devices including design, production, and post-market activities.
• CE Marking (EU MDR/IVDR), Knowledge of the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) for obtaining CE marks and ensuring market access across EU countries.
• ISO 14971, Risk Management & Safety, understanding in implementing risk management processes for medical devices identifying, evaluating, and mitigating risks throughout the device lifecycle.

• ISO 13485 Standard for Medical Devices- from A-Z, 2024
• Medical Device Regulation 2017/745 EU Regulatory Affairs, 2024
• ISO 14971 Medical Device Development and Risk Management, 2024

• Meenakshi Mission Hospital and Research Centre, Madurai, Tamil Nadu, Biomedical Intern, 5 Days, Training on testing & calibration of medical equipment
• Vadamalayan Hospitals, Madurai, Tamil Nadu, Hospital Intern, 7 Days, Upskilled on risk assessment & quality management; asset maintenance & documentation of medical equipment and classification of medical devices

• Father's Name: Murugesan K
• Blood Group: O+
• Date of Birth: 08/19/01
• Nationality: Indian
• Marital Status: Unmarried