As an established contract design and manufacturing partner for leading medical device OEMs, Creation’s manufacturing facilities are ISO 13485:2016-certified and FDA-registered. With the recent FDA-mandated UDI compliance date of September 24, 2016 for Class II medical devices, Creation has achieved internal 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.
“Creation Technologies is committed to exceeding all patient safety requirements on behalf of our innovative OEM medical customers. Achieving FDA UDI System compliance for all medical device classes in advance of the 2020 deadline demonstrates this commitment. Creation believes integrating critical UDI traceability information into our Vision system adds exceptional value,” said Tim Holzschuh, Director of Regulatory & Quality – Creation Design Services. “The medical device industry anticipates that the return on investment for the UDI System will include less reporting of adverse events, faster regulatory submission turn-around times, and more efficient post-market vigilance.”
Additional information about the FDA’s Unique Device Identification requirements can be found in UDI Basics and other resources on the FDA’s website.
About Creation Technologies
Creation (www.creationtech.com) provides total product lifecycle solutions including turnkey design, rapid prototyping, manufacturing and fulfillment to its customers around the world. Since 1991, Creation has been focused on making it easy for OEMs to ‘say yes’ to their customers. The company of approximately 3,000 people operates nine manufacturing locations, two design centers and a rapid prototyping center in the USA, Canada, Mexico and China. Its OEM customers are in the Industrial & Instrumentation, Medical, Communications, Transportation, Aerospace, Defense & Security, and Energy & Environmental markets.