 Trained Clinical Engineer
 New Product Development Process
 Design Controls Implementation as per QSRs (21 CFR 820); ISO 13485
 Compliance with FDA, MDD guidelines, cGMP, GDP
 Risk Management, ISO14971, DFMEA, UFMEA, Hazard Analysis
 Orthopedics, Spinal, Urological, IVF and Drug delivery devices
 CHU - Complaints Investigation & Analysis, Reliability Analysis, PMS, Regulatory reporting
 Design Verification & Validation activities
 Development of Design History File, Technical file, Design Reviews