Medical Device Link.

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Joseph Vinhais

A comprehensive software suite provides medical device manufacturers with a framework for regulatory-process management, helping prioritize compliance initiatives and mitigate risk. Introduced at MDM West 2006, the MEDIC suite from Brooks Software (Chelmsford, MA) can control critical data across operational and business systems, reportedly reducing lead times and improving visibility of the manufacturing process.

At a press conference on Tuesday, January 31, vice president of regulatory compliance Joseph Vinhais explained how the software helps manufacturers improve process control and flexibility while decreasing manufacturing costs. The software supports enterprise initiatives such as lean manufacturing, supply chain execution, and performance management. Suitable for enterprise businesses with multiple locations, the software enables manufacturers to adopt a holistic approach that addresses product design, quality control, traceability, and industry regulations and standards such as 21 CFR Part 820, ISO 13485:2003, GAMP4, and ISO 14971.

The MEDIC suite is designed to help manufactures link supply chain, manufacturing, and business systems within an interoperable environment that can adapt to market changes in real-time. The software suite includes all of the RFID hardware and software necessary to track equipment and inventory throughout the production process. Additionally, the software provides part tracking and device-history records that details production activity and lifecycle data.