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Design & Engineering
Mechanical Design
Rapid Prototyping
Reverse Engineering
FEM Simulation
Quality and Validation
Quality System Support
VMP - DQ IQ OQ PQ Validation
Standard Operative Procedures (SOP) (IOP)
Technical File / Design Dossier
Design Control
DHF Design History File
Risk Management Process
Clinical Evaluation
Testing
Mechanical Testing
Analysis on Plastics
Biological Safety Evaluation
TS Quality & Engineering is a ISO 13485 certified company. We offer solutions aimed at facilitating and speeding up the design, validation and quality control process. We follow the activities for testing and verification, we perform mechanical tests, tests on polymers, FEM simulations. Thanks to our network of certified suppliers and specialists we can always provide an high qualified support and guarantee a quick and focused service. We can follow the development of a new product at all stages.
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MEDICAL DEVICE NEW PRODUCT DEVELOPMENT (NPD) PROCESS
