Certified medical devices for minimally invasive aesthetic surgery

GMV is a company based in Rome, in which the most advanced technologies are made following the rules of Made in Italy and in compliance with European standards in terms of safety, quality and reliability. The ISO 9001: 2008 and EN ISO 13485: 2012 certifications for quality management are a confirmation of the professionalism of our company.

Our devices, certified according to the Directive 93/42 / EEC for medical devices, are made entirely in our company, from the idea and the prototype, up to production and sales.
In our Research and Development department, a group of engineers works constantly and passionately on the development of unique, high-quality and cutting-edge technologies.

The importance to choose a certified company and to use certified medical devices

CE MARKING

CE marking certifies that the product complies with the essential requirements required by the applicable EU Directives.

In the case of Medical Devices these are safety and efficacy requirements that both devices and their production system must possess.

ISO 13485

The standard harmonized with Directive 93/42 / EEC is the ISO 13485 standard: 2016 Medical Devices – Quality Management Systems – Requirements for regulatory purposes, which specifies the requirements for the Quality Management System of the Organizations producing Medical Devices and is aimed at proving that the Medical Devices and their services meet the legal requirements and the needs of the end customer.

ISO 9001

The ISO 9001 standard defines the requirements of a quality management system for an organization. The requirements expressed are of a general nature and can be implemented by any type of organization; last revision in 2015 (ISO 9001: 2015).

ISO 9001 is the reference standard for those who want to submit their production process to quality control cyclically, starting from the definition of the requirements (expressed or not) of the customers, reaching up to the monitoring of the entire production process / process.

The customer and his satisfaction are at the heart of ISO 9001; every activity, application and monitoring of the activities / processes are in fact aimed at determining the maximum satisfaction of the end user. The phases of application of the standard start from the definition of the procedures and registrations for each single process or macro process identified within the company organization.

Education

But GMV is not just manufacturing devices. GMV wants to be active in training, not only for the correct use of our machines, but also to implement standardized, effective and safe work treatments and protocols.

The educational offer includes advanced training courses in aesthetic medicine, monothematic courses in aesthetic medicine, workshops. Our events are also held in English and made available online in e-learning mode.

These values are the pillars of our training and are the basis of the new generation of GMV products, in which today we are able to disclose updates throughout the world and at the same time.

Plexr Plus - Introduction - Video