Promote coordination of regulatory requirements for medical device manufacturers on an international scale Companies that are ISO 13485 certified enjoy the benefits of an increasing number of customers who have more reason to trust and buy consistently high quality products. The management system according to ISO 13485 adopts a risk management approach which includes evaluation to identify & estimate risks, using risk controls and techniques with a view to eradicating hazardous situations throughout product realization. Assuring clients that products comply with all relevant product & service oriented technical standards & regulations. Emphasize cleanliness & sterility in the production area which in turn increases efficiency & improves safety in the workplace. Improved access to more markets globally. sertifikasi ISO 13485