Quality System

Fumagalli Care & Reha operates in all its divisions and for all its phases and processes according to the quality system that meets the standard UNI EN ISO 13485:2016.

Process control, evaluation and research tools

The design and production processes are fully procedurized and managed in a computerized manner (from the project to the bill of materials, from the management of the various production phases to the packaging) and are directly controlled by Fumagalli Care & Reha.

The evaluation and testing routines are managed within the company with appropriate equipment for the usual tests, while for the evaluation of prototypes and samples we use accredited external laboratories such as Catas and Lapi.

The level of computerization of the company is very high: each workstation is connected to the network and every process, from the insertion and confirmation of orders to warehouse and returns management, to the assessment of the percentage of failures, is fully computerized. A very sophisticated graphic workstation is active for the realization of projects and information material, for the interior design our architects have innovative programs at their disposal, while for the design of the aids the engineers make use of a three-dimensional CAD software.

All the projects for the new aids and processing cycles are made in Italy.

Certified company UNI EN ISO 13485:2016.
Download the certificate and the quality policy here