Quality and certifications

We are compliant with the international standard EN ISO 13485:2003 and we operate according to the Legislative Decree no. 46 dated 24 February 1997 (implementing the European Directive EU MDD no. 93/42/EEC).

The notified body for product conformity assessment is TÜV SÜD P.S. GmbH. We hold a quality management system certification in the medical field: this means that our products and services are compliant with current laws and regulations, thanks to the adoption of tested, controlled and constantly improved organisational models.

All medical devices, placed on the market, bear the CE marking: this proves that our products meet all requirements foreseen by Directive 93/42/EEC regarding, for example, safety, the choice of materials and biocompatibility.

The company boasts significant experience in product registration in extra-European markets. This procedure might often be particularly time-consuming and must be completed before the launch of new devices.

EN ISO 13485:2016 certificate

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