The GPMG ISO 13485 Quality System was originally developed to expedite factory relocation projects and to rapidly address quality system gaps identified during FDA QSIT preparation audits. The modularized approach also gives GPMG the ability to support the quality systems needs of start-up manufacturers and distributors who are typically faced with resource and cost challenges.
Common applications of the ISO 13485 Quality System are existing manufacturers with ISO 13485 Quality System or FDA QSR compliance gaps, 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.
Potential benefits of the Modularized ISO 13485 Quality System include:
• implementation can follow a logical sequence
• increases control over implementation process
• simplifies project management and tracking
• provides rapid solutions for a specific need
• adaptable to varying organizational structures
• reduces time to certification and compliance
• reduced resources and costs
Global Pacific Manufacturing Group LLC is a privately held global consulting firm providing engineering and manufacturing consulting services to the medical device industry.
Global Pacific Manufacturing Group LLC
Phone (202) 380-9380
Fax (815) 550-1702
Contact: Aaron Lyon
Phone: (978) 424-3936