Yes.ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices. ISO 13485 builds on the requirements of ISO 9001 by specifically addressing the responsibility of the device manufacturer for “maintaining the effectiveness of the quality management system.” That is why we have upgraded our certification to ISO 13485.
Custom Rapid Solution adheres to a thorough structure of North American operating procedures, which dictate the utmost in quality and process control. These procedures ensure that a client’s final product meets design specifications by consistently managing quality at each step in the production process. Custom Rapid Solution will work to ensure the success of your project from supplier selection to work-in-progress inspections, through final inspections, and in customer service. These quality management procedures include: