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Creation Technologies, award-winning EMS provider with electronics design, rapid prototyping and manufacturing locations around the globe, has announced its milestone achievement of the USA Food and Drug Administration (FDA) Unique Device Identification (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 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
Medical device and biotechnology companies working with Creation Technologies have scalable options for risk mitigation and rapid growth through the company’s turnkey solutions that include connected device design and development, rapid prototyping, manufacturing, fulfillment and logistics for complex systems, and VAVE and sustaining engineering.
With FDA-registered and ISO 13485-certified manufacturing facilities and design centers across Canada, USA, Mexico and China, Creation Technologies provides real-time visibility and traceability to its medical customers in markets from cardiovascular to urology imaging to radiation oncology.