- Ph.D. Biomedical Engineering
- M.E. Biomedical Engineering
- MBA Business Analytics
- B.Tech Information Technology
Dr. A. Shankar
Lead — Regulatory, Quality & Medical Device SoftwareBiomedical engineer and regulatory lead auditor with more than 20 years across healthcare software, medical-device quality systems and biomedical research. He audits quality management systems and technical files against ISO 13485, EU/UK MDR and MDSAP, and trains engineering teams on the IEC 62304 and IEC 82304 health-software standards.
At SKCore he leads regulatory strategy, software-lifecycle quality and safety-by-design.
- ISO 13485 · EU/UK MDR · MDSAP
- IEC 62304 / 82304
- ISO 14971 risk management
- SaMD & embedded software
- Health-data security
- CQI-IRCA Lead Auditor — ISO 9001 and ISO 13485
- Two registered copyrights (software audiometer, integrated telehealth platform); peer-reviewed papers in AI, medical imaging and brain-computer interfaces
