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.decimal® is an ISO certified company. ISO (International Standards Organization) is a network of the national standards institutes of 156 countries. To maintain certification .decimal® must pass a stringent audit each year to verify .decimal® is conforming to all of the requirements of each system.
Achievement of ISO certifications demonstrate a corporate commitment to quality that spans all levels of the organization. They are stringent, globally-recognized standards for medical device manufacturers and service providers and they demonstrate that .decimal® has built a quality system which continuously strives for improvement while maintaining the safety and effectiveness of its medical devices.
ISO 9001 Quality Management System Certification
An ISO 9001:2008 certification means that .decimal® focuses on specific quality requirements and applicable regulatory requirements, while working to enhance customer satisfaction and achieve continual improvement in pursuit of these objectives.
ISO 13485 Medical Device Quality Management System Certification
An ISO 13485:2003 certification means that .decimal® demonstrates its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
Canadian Medical Device Establishment License