Quality is the basis of VISIA Imaging.
Each project originates from the customer requirements and is executed ensuring accuracy, reliability and safety in accordance with quality standards and applicable regulatory requirements.
All processes and activities leading to the realization of our products, are planned, executed and monitored in accordance with the quality principles and regulatory requirements in the complex field of medical/diagnostic equipment, with a view to continuous improvement.
A multi-disciplinary team, at each stage of the project, must be composed of skilled technical personnel in terms of quality and regulatory. This is the key to obtaining technologically advanced, safe and effective products from all perspectives.
The VISIA Imaging Quality Management System complies with the following internationally recognized standards:
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.
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