Creation Technologies Launches FDA UDI Compliance Program in Global Manufacturing and Design Operations
Thursday, October 27, 2016
Creation Technologies, award-winning EMS provider with electronics Design, Rapid Prototyping and Manufacturing locations around the globe, today announced its milestone achievement of the USA Food and Drug Administration (FDA) Unique Device Identifier (UDI) Compliance for Class I, Class II and Class III medical device labeling across its global operations.
As an established contract design and manufacturing partner for leading medical device OEMs, Creation’s manufacturing facilities are ISO 13485-certified and FDA-registered. With the recent FDA-mandated UDI compliance date of September 24, 2016 for Class II medical devices, Creation has achieved compliance with the regulation. Moreover, the company has announced implementation of a proprietary new tool and automated process within its Vision manufacturing execution system and customer portal that enables its customers to obtain real-time data and device tracking information in support of their UDI compliance.