Quality
General Medical Italia Ltd has achieved the following certifications:
ISO 13485 is an international standard that outlines the requirements for a Quality Management System in the medical device industry.
This standard is specific to medical devices and covers the entire life cycle of a device, from design and development to production, installation, and servicing.
It is intended to ensure that medical devices are safe and effective for their intended use.
Compliance with ISO 13485 is often required for regulatory approval of medical devices in almost countries around the world.
EU MDR stands for European Union Medical Device Regulation. It is a set of regulations that govern the safety and performance requirements of medical devices in the European market.
The aim of the EU MDR is to ensure the highest level of patient safety and provide greater transparency and traceability of medical devices throughout their lifecycles. The EU MDR was released by the European Parliament and the Council of the European Union.
The intent of the European medical device regulations is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.
The General Medical Italia Ltd, has certified the following products family, and more are in progress, all compliant at new medical devices regulation (MDR 2017/745):
LUCERNA RF-TILT (Series)
LUCERNA U-Arm (Series)
GENE'VE 40 M (Series)
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU).
It serves as a central hub for information related to medical devices within the European Union.
