Design Control and Regulatory Services

ZIEN can act as the “Legal Manufacturer” for your product under our ISO13485:2016 certification and FDA site registration. Within this QMS ZIEN provides full design control and regulatory services capable of FDA clearance and CE Marking activities. These services allow us to develop products for our customers that fulfill all product and regulatory requirements and achieve market release up to 9 months faster than going it alone. Within our QMS ZIEN can take your product from concept to commercialization in a proven system and get you to market faster and with less cost.