Global Pacific Manufacturing Group Develops ISO Quality System for Implementation in Medical Device Companies

Gardner, Mass.-based Global Pacific Manufacturing Group LLC (GPMG) has developed an ISO 13485 U.S. Food and Drug Administration (FDA)- and Quality Systems Registrars Inc. (QSR)-compliant quality management system (QMS) in a modular format designed for rapid implementation and integration. GPMG provides manufacturing and engineering consulting to medical device companies. This ISO system will be marketed to medical device companies seeking to achieve the ISO certification for their QMS.

According to GPMG, its system consists of a complete ISO 13485 quality system crafted into four logical modules that can be installed in its entirety. Another option would be for specific modules or individual standard operating procedures to be integrated into a company’s existing system to address areas of non-compliance.

The GPMG ISO 13485 Quality System originally was developed to expedite factory relocation projects and to rapidly address quality system gaps identified during FDA quality system inspection technique preparation audits. The modularized approach also will help GPMG support the quality systems needs of start-up manufacturers and distributors that typically face resource and cost challenges.

Companies that can benefit from the ISO 13485 Quality System are existing manufacturers with gaps in their compliance requirements, new divisions or medical device start-ups, medical device distributors, medical device brand-only companies outsourcing manufacturing activities, contract product design facilities, and contract service providers.

Features of GPMG’s new ISO system include reduced time to certification and compliance, increased control over implementation systems, and lower costs.