Many years of effective, well organized work have led to the recognition and support available to us by achieving compliance with safety regulatory requirements.

Our Quality Management System is designed to meet ISO 9001 and ISO 13485 standards, as well as the Quality System Regulation (QSR) established by the FDA (USA). We have also obtained the BPF (Good Manufacturing Practices) certificate issued by the ANMAT. To guarantee reliability and electrical safety, all our units also comply with the UNE-EN 60601-1 standard and its provisions.
Lastly, the CE marking conforming to the Directive 93/42/EEC (European Economic Community) and the FDA (USA) guidelines allow us to export our products virtually the world over.

We are proud to be able to fulfill the most demanding international quality standards since they enable us to guarantee the reliability expected from us.


Our Quality Management System is designed to meet the following standards:

ISO 9001     “Quality Management Systems - Requirements” (International) View certificate

ISO 13485    “Medical devices - Quality management systems - Requirements      for regulatory purposes" (International) View certificate

	BPF    “Good Manufacturing Practices for medical devices” (Argentina)    View certificate
	Manufacturing establishment licensing issued by ANMAT    (National Food, Drug and Medical Technology Administration) View certificate

QSR     “Quality System Regulation” FDA (USA)

Standards that guarantee the safety of our products:

	UNE-EN 60601-1     “Medical electrical equipment – General requirements for safety”    UNE-EN 60601-1-2     “Medical electrical equipment. Part 1-2: General requirements for     safety. Collateral standard: Electromagnetic compatibility.     Requirements and tests”
	UNE-EN 60601 standards setting forth device-specific safety     requirements.