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STATICE santé,
Production Engineering and Industrialisation Department
3 technicians specialised in tool creation, process
validation, and industrial organisation.
Based on the study file and the quotation, the Production Engineering
and Industrialisation Department will design and make the tools for the
transformation of the materials as well as the assembly tools. It will
ensure, by manufacturing the parts, that it has full command of the manufacturing
process and will draw up a manufacturing file.
The means used by the Production Engineering and Industrialisation
Department are:
- CAD,
- CAD/CAM,
- Numerical controls,
- Tooling workshop,
- Clean room.
At the end of this stage you will have a manufacturing file
for the tools and components with:
- drawings of the tools,
- assembly drawings,
- definition drawings
- lists of parts
- drawings of assembly equipment
- assembly drawings,
- definition drawings
- lists of parts
- production procedures,
- general inspection procedures.
- a tool validation file (metrology),
- a file concerning the product packaging
- labelling,
- packaging in blister packs with the design and the manufacturing
of tools for the production of the blister packs,
- the outer packaging.
- a quality file
Along with information on the biocompatibility of the materials,
the quality certificates, the sterilisation validation documents (initial
contamination) and the validated sterilisation process.
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