In compliance with the necessary standards.
Our quality systems are assessed and certified as per the guidelines of ISO 9001:2015 and ISO 13485:2016.
Our Products conform to the stringent quality norms of CE, as specified by European Council’s Medical Device Directive (MDD) contained in 93/42/EEC, as well as Regulation (EU) 2016/425.
Most of our Radiation Protection Products meet or exceed EN 61331-1:2014, EN 61331-1:2014, ASTM F 2547, EN 388:2016, EN 420:2003 + A 1:2009, DIN & IS Standards. Our manufacturing facilities are registered with USFDA.
