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Certifications, Quality Management System, and Customer Satisfaction

Quality Management System

Each stage of the production process includes monitoring and control activities, from incoming materials to final release. Throughout all phases of production, accurate visual and dimensional inspections, as well as functional and safety tests, are carried out. All company processes are planned to ensure compliance with the applicable regulatory and normative requirements.

We plan our quality through:

A Quality Management System certified in accordance with international standards
ISO 13485 Certification
CE Certification in compliance with Directive 93/42/EEC and the subsequent Regulation (EU) 2017/745
A production system managed through procedures and instructions for the control and traceability of the entire production process
Validation of production processes

We control our quality through:

A documented control system at every production stage:
– Incoming inspections
– In-process inspections
– Final inspections
Quality control plans in accordance with ISO 2859
Visual, dimensional, functional, and technical tests on components and finished products

We ensure our quality through:

Continuous monitoring of products on the market
Product monitoring through feedback from patients, medical studies, and healthcare professionals
Functional testing performed on products from batch archives

ISO 13485:2023 Certification
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CE Certification in compliance with Directive 93/42/EEC and subsequent Regulation (EU) 2017/745
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Customer Satisfaction
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Press Release

ADNKRONOS: “Sexuality, a revolutionary discovery: the supplement against impotence”

Announcement by the director of the Center for Reproductive Medicine and Biology of the European Hospital in Rome and member of the Italian Society of Andrology, Ermanno Greco, who speaks to ADNKRONOS Salute about the historic discovery for its definitive cure: “It is linked to a deficiency of nitric oxide”. Almost 4 million Italians with…

Erectile dysfunction, Prof. Ermanno Greco interview

World Sexual Health Day will be celebrated in Rome on 10 September. In view of this important event, some data from a survey promoted by the Institute of Clinical Sexology have been made public. By Miriam Giangiacomo We commented on them together with Professor Ermanno Greco, andrologist and Director of the Center for Reproductive Medicine…

Erectile dysfunction, the therapy to overcome

by Antonio Caperna ROME – Only the name once aroused shame and concern in the man and his partner. Today, however, impotence is a disease that can be overcome 100%. «The old term impotence is today scientifically replaced with erectile dysfunction or the inability to obtain or maintain an erection valid enough to have a…

Sexuality, a “no flop” supplement heals erectile dysfunction

In Rome, tests on a substance capable of resolving a form of impotence that affects three million Italians in 85% of cases. The trial, conducted so far on a small sample and for a limited period, has ruled out side effects. The results of the study will be presented at the congress of the Italian…