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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 demonstrates 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 that continuously strives for improvement while maintaining the safety and effectiveness of its medical devices.
ISO 13485 Medical Device Quality Management System Certification
An ISO 13485:2016 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