Injection Molding
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
We are specialized in the development of devices to be manufactured by injection molding process, with particular refer to medical and implantable devices produced in a GMP regulated enviroment. We follow the complete product development from the first concept to the production phase, but we can also provide our support in a specific phase.
The realization of a new device is carried out following different phases.
We are able to follow the development and realization of a new device to be produced through injection molding at all stages.
We are specialized in the design and manufacture of molds for the medical industry, we follow the validation of the whole process in order to realize a product that meets design specifications and fullfill all required quality and regulatory requirements.