Certifications

ISO 13485:2003

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.

ISO 9001:2008

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 14001:2004

An ISO 14001:2004 certification means that .decimal takes steps to minimize harmful effects on the environment caused by our manufacturing activities and works toward continual improvement of our environmental performance.

.decimal is an ISO 13485, 9001, and 14001 certified company. International Organization for Standardization (ISO) is a network of the national standards institutes of 156 countries. To maintain certification .decimal must pass four stringent audits each year that verify .decimal is conforming to all of the requirements of each system. An ISO 13485 certification is a baseline necessity along with the CE-Mark, which is a mandatory conformity mark on products placed in the European Economic Area. The CE-Mark certifies that products have met EU health, safety, and environmental requirements, ensuring consumer safety. Both of these certifications grant .decimal approval to sell medical devices in many key markets.

Achievement of ISO certifications and the CE-Mark 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.