The Company is running a modern (and high) Quality Management System focusing on controlling processes and building in quality from the early stages. The Company is Certified With DIN EN ISO 13485 : 2012 (Switzerland & Spain) and CE Mark standards according to Medical Device Directive 93/42/ EEC (Annex II, Annex II.4 and Annex V)
Risk management throughout the development process is a company’s key tool.
Outstanding fast time of response is a key feature of the company. The importance of each single customer and physician is well-known by all the organization.
Ballon Forming Machine