GPMG's Vice President and General Manager, Aaron Lyon notes that "This new product will allow medical device developers seeking ISO 13485 certification to meet 85-90 percent of their goal on day one. The remaining effort is on aligning the system with any unique activities and the company's organizational structure. The product allows companies to focus on product development instead of quality system development."
The procedures guide development teams to identify user needs, define product performance requirements, and convert user needs into technical specifications. Design reviews, conducted at each stage of development, use detailed forms that offer guidance on topics reviewed and serve to document each review.
The system includes application of risk management per ISO 14971 and design analysis tools. The system also addresses the content and construction of Design History Files and Device Master Records and the management and control of documentation. Controls over materials, supplier management, and corrective and preventive actions are also included. Further, GPMG has developed numerous individual procedures that can easily be added to the base system to match each company’s unique business activities.
The system installation follows GPMG’s long-established approach of Adopt, Align, Train, and Certify:
· Adopt the system to match an organizations products, markets, and policies.
· Align each procedure with the manufacturer’
· Train core staff in a logical sequence
· Provide ongoing support until certification.
GPMG is confident medical device specification developers seeking ISO 13485 certification and FDA QSR compliance will take full advantage of this cost-effective solution.
Global Pacific Manufacturing Group LLC is a privately held medical device consulting firm that assists medical device manufacturers with product development and regulatory compliance globally.
To learn more about Global Pacific Manufacturing Group LLC products and services visit them at: www.gpacmfg.com
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