HISTORY OF A
- Technological Development
LThe 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 the devices and their production system must possess.
Harmonized standard of Directive 93/42 / EEC is the standard ISO 13485: 2012 Medical Devices – Quality Management Systems – Requirements for regulatory purposes, which specifies the requirements for the Quality Management System of Organizations that produce Medical Devices and is aimed at demonstrating that the Medical Devices and related services meet the legal requirements and the needs of the end-user.
The ISO 9001 standard defines the requirements for 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 subject their production process to quality control in a cyclical way, starting from the definition of the requirements (expressed and not) of the customers, arriving to the monitoring of the entire process/production process.
The customer and his satisfaction are at the center of ISO 9001; all activity, application and monitoring of 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.
GMV MEDICAL DEVICES HAVE BEEN APPROVED BY THE EUROPEAN COMMUNITY
AND FROM NOTIFIED BODIES AND GOVERNMENT ENTITIES AROUND THE WORLD
GMV MEDICAL DEVICES ARE USED
IN OVER 50 COUNTRIES AROUND THE WORLD
Azerbaijan, Bosnia, Bulgaria, Croatia, Cyprus, Czech Republic, Danimarca, England, France, Georgia, Germany, Greece, Hungary, Italy, Montenegro, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, Ukraine, Uzbekistan
Brasil, Canada, Colombia, Dominican Republic, Mexico, Perù, Usa
Bahrain, Egypt, Indonesia, Iran, Iraq, Israel, Japan, Jordan, Korea, Kuwait, Oman, Qatar, Saudi Arabia, Singapore, Taiwan, Thailand, United Arab Emirates, Vietnam
Algeria, Lebanon, Marocco, South Africa, Tunisia
Australia, Nuova Zelanda