/ http://www.slideshare.net/images/logo.gif / ºÝºÝߣShare feed for ºÝºÝߣshows by User: ankzii https://cdn.slidesharecdn.com/profile-photo-ankzii-48x48.jpg?cb=1626943747  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