Avandhika S Kumar
Quality Assurance Regulatory Affairs @Ss Innovations International, Inc
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WORK HISTORY
Quality Assurance Regulatory Affairs @Ss Innovations International, Inc
Gurugram, IN
Involved in Regulatory Affairs and Quality Assurance activities for the SSI Mantra 3.0 robotic surgical system.Supported preparation and compilation of regulatory dossiers in line with EU MDR (2017/745), and Medical Device Rules (MDR) 2017 – India.Contributed to clinical evaluation activities, including support in Clinical Evaluation Reports (CERs), literature review, and clinical data assessment for robotic surgical devices.Coordinated with cross-functional teams (R&D, Clinical, Quality) to ensure regulatory and quality compliance throughout the product lifecycle.Maintained and updated the Document Control Index (DCI) and tracked SOPs, formats, and records across departments.Assisted in preparation and review of technical documentation supporting global regulatory submissions for robotic surgical systems.
EDUCATION
Sahrdaya College of Engineering & Technology (Autonomous)
Bachelor of Technology - BTech, Biomedical/Medical Engineering
ABOUT AVANDHIKA S KUMAR
Regulatory Affairs and Quality Assurance professional in the medical device industry with experience supporting ISO 13485 quality management systems and regulatory activities in compliance with EU MDR, IMDRF guidelines, FDA requirements, and the Medical Devices Rules, 2017 (MDR 2017 – India). Actively involved in regulatory documentation, clinical evaluation support, literature review, and quality compliance processes for advanced medical technologies, including robotic surgical systems.
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