Dr. Sudhi Gautam

San Francisco Bay Area US

Medical Director - Medical Safety Physician

Medical / Health Care / Pharmaceuticals

Bring a blend of Surgical, Medical Device Engineering and Safety expertise very important for medical device product success. Experience spans – New Product Development & Safety • Medical device safety, Reliability, Risk Management, ISO 13485 Auditing, FMEA, Complaints handling, Clinical Design of Experiments, Statistical methods, Data Mining • Working knowledge of Adverse Events Reporting, Complaints handling, medical significance of incoming safety information and compliance with reporting requirements; • Highly commended for successful accomplishment of Clinical validations Phase IV type post-market trials and Pre-clinical trial evaluations/submissions of cutting edge M...