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3D Tasarım · 10 aydır üye

İzmir Menderes

BAŞLA

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Güvenlik Kontrolleri

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Medical Device Technical File Consultancy Process Validation CAPA (Corrective and Preventive Actions) Internal and External Audit (EU) MDR 2017/745 & ISO 13485 Risk Management Post Market Surveillance Product complaints Implantable medical devices Biocompatibility assessment and evaluation of test reports Determination of performance tests and evaluation of reports Use of quality control equipment (caliper, micrometer, profile projection, gauge) Management of validation processes of dental implant manufacturing processes Documentation and effective implementation of ISO 13485 Quality Management System in departments Coordinator of audits carried out by Notified Bodies in English language Design and preparation of quality drawings of 3D dental implant products thanks to SolidWorks design knowledge Active role in design inputs, outputs, review, verification, validation, validation, serial production approval processes Risk analysis of processes & reporting of benefit risk analysis Knowledge of manufacturing and test processes Implementation of standards, regulations and guidelines in all processes. Management of critical supplier processes Detailed information about production methods and processes (CNC sliding vending machine, heat treatment, sharpening, ultrasonic washing, electropolishing, laser marking, clean room) Input, inproses, final control and release

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