Complying with UDI requirements

Complying with UDI requirements

Systech Int'l and Tata Consultancy Services partner to help medical device manufacturers adhere with the pending FDA UDI legislation.

May 15, 2014
Manufacturing Group
Contract Manufacturing Industry/Regulations People/Facilities

Cranbury, N.J. – Systech International officials announce its partnership with Tata Consultancy Services (TCS) to supply medical device manufacturers with a means of complying with pending FDA Unique Device Identification (UDI) requirements.

Part of UDI rule establishes that each model or version of a medical device should be assigned a Unique Device Identifier and a part of this information be reported to the FDA Global Unique Device Identification Database (GUDID) where it is accessible to the public.

Systech and TCS have jointly developed an end-to-end UDI solution which addresses Master Data Management (MDM), System of Record for UDI, and Interface with labelling solution at the packaging lines. The solution works by integrating different data sources to create a single platform on which manufacturers can maintain and locate master device identifier information. The platform then transmits this information to GUDID, ensuring manufacturer compliance.

In addition to managing device identifier information, the platform can be extended to individual manufacturing sites where it can be used to manage the assignment and application of Unique Production Identifiers to devices and device packaging.

“The TCS-Systech UDI platform not only offers manufacturers a means of meeting initial device identifier reporting requirements, but as importantly, a centralized platform that can manage production identifier data throughout an enterprise,” said Barry McDonogh, VP Business Development at Systech.

Regu Ayyaswamy, Global Head - Engineering and Industrial Services, TCS said, “The TCS-Systech UDI solution provides a unified platform to medical device manufacturers with traceability throughout the supply chain. Medical devices and diagnostics customers can benefit from TCS’ global presence for enterprise-wide UDI solution implementation, covering their global facilities.”

Source: Systech International