and maintain high-quality design inputs/outputs, DHF documentation, DFMEA/PFMEA, verification evidence, and change records...
Design History File (DHF), risk management files, and verification/testing strategies to ensure compliance with QMS standards...
, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF...
, verification protocols, and DHF content. Executes new devices, processes, equipment, materials, verification and validation...
of design controls, risk management (FMEA, hazard analysis), V&V, and DHF readiness. Quality as a Strategic Enabler Embed...
, human factors, regular review of DHF, combination product launch activities, device product complaints, and post-market...
(simulation, prototyping, bench testing, performance testing) Author and maintain technical documentation supporting DHF...
, ensuring all activities adhere to ISO 13485 Design Controls and are fully documented in the Design History File (DHF...
reviews and perform periodic review and update of DHF and RMF. Review design inputs, outputs, and verification/validation...
guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF...