Balts Certifieringar och registreringar
Balt´s quality certificates and international registrations:
- ISO 9001 (2000)
- NF EN ISO 13485 (2004)
- Directive Européenne 93/42/CEE
- Foods and Drugs Administration FDA- USA (some products only)
- TGA – Australia
- KFDA – Korea
- HEALTH CANADA
- PMDA – Japan
Quality is one of BALT’s main focus
The Balt quality is the continuous research on products more user-friendly, simple and always more reliable in its use. The pillar to this adequacy with clinical practicians’ gestures is that Balt always pays particular attention to its devices users’ opinion.
The quality of Balt products is also a steady research on materials and manufacturing methods. The quality of Balt products reveals not only a consistent manufacturing, a strict unit control and quality assurance procedures for each manufacturing step. It is also a firm certainty in a rigorous control of raw materials, biocompatibility and apyrogenicity.
Finally, Balt’s quality is the key element to the ongoing policy of improvement brought to extrusion, injection & assembling methods. Manufacturing staff of 50 people is being permanently trained in order to guarantee Balt’s performance and the quality of its devices.
Main BALT technical innovations
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