Certifications and Documents

Each project stems from the need to satisfy customer requests, and is developed ensuring precision, reliability, safety, in compliance with the highest quality standards and every applicable regulatory requirements.

Quality is one of the main pillar of VISIA LAB

All the processes and activities that lead to the creation of our products are planned, executed and monitored according to the principles of quality and the regulatory requirements that govern the complex sector of medical & diagnostic devices, with a view to continuous improvement.

A multidisciplinary team, which involves experienced quality and regulatory personnel in every phase of the project, is the key to obtaining technologically advanced, safe and effective products, which satisfy the customer from all points of view: qualitative, technical and compliance with current regulations.

The training and constant updating of personnel are strategic activities and essential conditions for the achievement 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 excellence in the execution of the relevant process phases.


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

For the European market, our products are CE IVD marked according to current regulations and tested according to the applicable industry standards (IEC 61010, IEC 61326 etc.) for electrical safety and electromagnetic compatibility by accredited laboratories. We are able to support any other kind of non-EU product standard.

MDSAP (Medical Device Single Audit Program).

The MDSAP program allows bodies (Auditing Organizations – AO) recognized and accredited by the Regulatory Authorities of the five participating countries (U.S.A., Canada, Brazil, Japan and Australia) to conduct a single audit at the manufacturers of Medical Devices to verify that the latter satisfy the Quality System management requirements (GMP: Good Manufacturing Practice) of the reference countries.

Downloads / Documents

Visia Lab is a leading Italian company in the In Vitro Diagnostics Device technology sector.

Request documentation and techincal sheets of our products

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