Expertise

Quality

Quality is the foundation of VISIA Imaging

Each project arises from the requirement to meet the needs of our customers, and it is developed ensuring precision, reliability and safety in accordance with quality standards and applicable regulatory requirements.

All the processes and activities that lead to the realization of our products are planned, performed and monitored according to the quality principles and regulatory requirements that regulate the complex sector of medical / diagnostic devices, with a view oriented towards a continuous improvement.

A multidisciplinary team, who involves skilled personnel in quality and regulation in every phase of the project, is the key to obtain technologically advanced, safe and effective products which satisfy the customer from every point of view: qualitative, technical and in accordance with the existing regulations.

The constant training and updating of personnel are strategic activities and essential conditions for the realization of continuous improvement within the company and for the achievement of quality objectives.

Each employee is involved, motivated and sensitized in order to ensure the highest level of quality in the execution of the process phases of their own relevance.


Certification

The VISIA Imaging Quality Management System complies with the following internationally recognized standards:

UNI EN ISO 9001: 2015

EN ISO 13485: 2016

Furthermore, in February 2018 VISIA Imaging was among the first companies in Italy to obtain the certification of compliance with:

MDSAP (Medical Device Single Audit Program) requirements

This certification certifies the compliance of the Quality Management System with the regulatory requirements of the competent authorities of the countries participating in the program: USA, Australia, Brazil, Canada, Japan.

For the European market, our products are CE marked according to current regulations and tested according to applicable industry standards (IEC 60601, EN 61010, IEC 61326 etc.) for electrical safety and electromagnetic compatibility from accredited laboratories.

How we design


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