CAMP MEDICA GROUP

has open in  2009 his own rapid tests production line in Bucharest, becoming so first Romanian manufacturer of lateral flow tests (rapid tests for in vitro diagnostic).

 

We have implemented and we maintain a Quality Management System in order to meet our Romanian regulatory requirements for product approvals and to provide the highest quality product to our customers.  These systems are SR EN ISO 13485:2016 and SR EN ISO 9001:2015 certified and compliant with  the European Union Directive 98/79/EC of In Vitro Diagnostic Medical Devices .  Certification and compliance to these requirements attests to Camp Medica’s ability to maintain the highest standard of quality in medical device manufacturing and product development.