TOWARDS SHARED SUCCESS
FOR TOTAL QUALITY
QUALITY IS THE KEY TO PERFORMANCE
Our long-established firm has always aimed to satisfy your most demanding
requirements. That is why we have implemented a Quality Management System (QMS), guaranteeing that our processes are reliable and rigorous. To guarantee conformity with very specific requirements, we have drawn up our quality manual to comply with the requirements of Standard ISO 13485:2016.
Our QMS enables us to guarantee the quality and traceability of your prototypes, right up to final delivery of the product series. So we can meet all your needs, including individual specifications. We help you move your device on from the research laboratory to the market, by helping you with validation of functionality, safety of materials, and compliance with manufacturing standards through the maintenance of technical files. Our quality process covers all our services and all our managers.
We maintain a regulatory watch to ensure continuous compliance with the latest regulations.
In today’s increasingly competitive market, outsourcing has become an essential commercial strategy for manufacturers of medical devices. The most successful partnerships are much more than a simple supplier relationship. They are a natural and integral extension of the business of the device manufacturer.
WE GUARANTEE YOU:
– A workforce highly qualified in machining and assembly of micro components
– Climate controlled manufacturing workshop with high performance automatic CNC machines
– Premises and equipment suitable for the assembly of microtechnic devices (ESD, climate controlled, secured)
– Ensuring compliance with delivery
– Optimal project management
ISO 13485 – NO COMPROMISE ON QUALITY, GUARANTEED SAFETY
The ISO 13485:2016 standard defines a quality management system specific to medical devices and includes risk management and traceability requirements.
OUR FIELDS OF ACTIVITY
– Manufacture of microtechnic sub-assemblies for medical engineering, metrology and instrumentation
– Machining of extra-hard materials (sapphires, rubies, ceramics and carbides)
– Production of components for metrology