Our commitment to continually increasing the quality of our service and the satisfaction of our customers are essential elements of our company's culture and values and are a fundamental aspect of our business processes and systems.
All administrative, commercial, logistic and production processes, as well as the design, are also subject to an internal Quality Management System, according to the following regulations (certificates can be downloaded at the bottom of the page):
- UNI EN ISO 9001: 2015 Quality Management System - Requirements
- UNI CEI EN ISO 13485: 2016 Medical devices - Management systems for quality - Requirements for regulatory purposes
- UNI EN ISO 14001: 2015 Environmental management systems - Requirements and guidance for use
- UNI ISO 45001:2018 Occupational health and safety management systems — Requirements with guidance for use
Mediberg has drawn up its own Policy for Quality, Environment and Safety (downloadable at the bottom of the page), which it shares with its Stakeholders.
In addition to system certifications, Mediberg has a certified system for the CE marking of its medical devices. and has had an in-house design department since 1998.
Mediberg, equipped with an internal Technical Department, is therefore able to design, manufacture and place on the European market even complex medical devices, such as procedure packs containing class III medical devices: this has allowed Mediberg to be certified under Annex II according to Directive 93/42/EEC
Mediberg sells its own non-sterile Class I Medical Devices in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices
and related MDCG.
Mediberg is also a manufacturer of Personal Protective Equipment according to Regulation (EU) 2016/425 of the European Parliament and of the Council on Personal Protective Equipment
. Relevant declarations of conformity can be found below.