About 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...