Request for valid company certifications
- Quality certification N.9120.GARD IN ACCORDING TO ISO 9001:2008 issued by CSQ
- Quality certification N. 9124.GAR2 IN ACCORDING TO ISO 13485:2012 issued by CSQ MED
- Quality certification N. IT-1563 IN ACCORDING TO ISO 9001:2008 issued by IQNET
- Quality certification N. 2017_08_197/Q IN ACCORDING TO ISO 14001:2004 issued by ICM
- CE COMFORMITY CERTIFICATE N.789/MDD IN ACCORDING TO 93/42/EC FOR MEDICAL WEIGHING DEVICES ISSUED BY THE NOTIFIED BODY N. 0051 (IMQ SPA DI MILANO)
- CE COMFORMITY CERTIFICATE N. DGFDM/III/P I.5.l.e.1/2011/613 IN ACCORDING TO 93/42/EC FOR MEDICAL DEVICES ISSUED BY THE MINISTRY OF HEALTH
- CcERTIFICATE N. E112961 IN ACCORDING TO US National standard ANSI/AAMI ES60601-1: 2005 /A2:2010 and CAN/CSA-C22.2 No. 60601-1:08 ISSUED BY “MET LABORATORIES, INC.”
- APPROVAL CERTIFICATE ATLAB-I16- 012/0 REV. 0 IN ACCORDING with the requirements of the Council Directive 2014/31/UE, annex II Module D: NAWI Non automatic weighing instruments manufacturing ISSUED BY NOTIFIED BODY N.2081
- TYPE APPROVAL CERTIFICATE ISSUED BY THE MINISTRY OF ECONOMY – N. I 04 – 018
The Quality Management Representative is responsible for preparing, implementing and upgrading all the processes involved in the Quality Management System.
Due to the pursued goals, Gardhen bilance has taken the strategic decision to internationalize its marketing activities and continuously improves both internal and external processes in order to achieve growing competitiveness.
Positive results have confirmed that the decision has been visionary and has led to an increasing number of distributors covering areas all over the world; for this reason, the company is continuing to maintain and to consolidate its activities as well in international markets.
By participating in national and international fairs and medical congresses all over the world, we continuously acquire greater knowledge of the market and its evolution. The same events give to Gardhen bilance the possibility of listening to the needs and expectations of the customers, both consolidated and potential ones.
The information gathered in these occasions represent a constant stimulus to face the challenges of the market, so that day by day the company is concerned with renewing and extending the range of products.
Gardhen bilance is well known as manufacturer of chairs and beds with integrated scales, hospital chairs and beds as well for home use, tilt tables and other specific medical devices, all complying with the European directives 93/42/CEE and 2007/47/CEE. Our goals are the application of the Quality Management System and of all the rules and European directives required for our medical devices. Supervision is carried out by the
Notified Body 0051 and 02081. The Quality Management System is in compliance with ISO 9001:2008 and ISO 13485:2012. The cMETus certification of MET Laboratories enables Gardhen bilance to sell its medical
devices as well in the countries of the North American continent.
Most of the medical devices made by Gardhen bilance are produced in stainless materials.
During the complete procedure of analyses, project planning and production, applying advanced technology, know-how and considering the current directives, stainless materials have take care of the safety of the patients and the health workers.
It is estimated that every year, as a consequence of corrosion, the social cost in industrialized countries amounts to about 5% of GDP. Currently, stainless materials represents the most efficient solution to this problem.