Research and development
Technological laboratory for component validation
The Research, Development and Design departments make use of updated software such as: SOLID MODELLING, RAPID PROTOTYPING and REVERSE ENGINEERING SOFTWARE.
Thanks to a highly motivated staff with excellent skills, it is possible to have a direct confrontation to analyze and propose innovative solutions for various medical applications.
The Research & Development Department has a qualified laboratory.
Modern technological measurement and control equipment, periodically validated by SIT accredited calibration institutes, guarantee the execution of appropriate functional and dimensional tests for component validation.
The most recent research is oriented towards the upgrading of plastic moulding processes for medical use, the Automation of Production Processes, and the Management of Visual Control Systems
Integral to R&D is the Quality Control Department, equipped with the best metrological and measuring equipment and a modern test laboratory.
Technology
A valuable and distinguishing feature is the significant ability to reduce time to market.
Thanks to its own rapid prototyping systems, the development of new ideas, new products and new processes is facilitated, aimed at entering new technological markets worldwide.
Quality
Quality at 360°
COMEF, as a manufacturer of components for medical devices, has always been orientated towards customer satisfaction and compliance with the safety and reliability requirements of its products, with a “process approach” and “risk approach” vision.
The company management confirms its commitment to develop and implement the Quality Management System, to keep it active and effective by continuous improvement.
The activities carried out in the areas of Quality, Research, Production, Logistics play a key role in successfully meeting the challenges of the market and therefore operates with all-round quality procedures.
The company is characterized by culture of quality.
From the realization of the project, through experimentation and industrialization, to the production and sale of the product.
Every company process is monitored, measured, and analyzed to verify the achievement of predefined objectives.
Certified quality
Quality Certification embodies the company’s strategic philosophy of global improvement, ensuring the conformity of its products and services.
This quality policy enabled the company, back in 1995, to obtain Certification of conformity to the international standard ISO 13485
In 2018 we reached a new milestone, obtaining the certification:
ISO 13485: 2016 Medical Devices – Quality Management System
All areas of our business have adapted to the new requirements of the standard to continue to improve our product performance and compliance with customer requirements.
Currently, the new Medical Device Regulation EU 2017/745 (MDR) and EU 2017/746 (IVDR) are pushing us to improve again by setting a new goal: to use only safe plastics, which do not contain any of the hazardous substances CMR, ED, etc. listed in the new regulation.
Here you will find our new certificate in annex.