ABEL Achieves ISO 13485:2003 Certification
Today, ABEL achieved ISO 13485:2003 certification which is a quality management standard for medical devices.1 ISO 13485:2003 builds upon ISO 9001, the standard that provides a set of standardized requirements for a quality management system, but includes specific requirements unique to the design, development, manufacture, and maintenance of medical devices.
Offering our customers both high performance and safe software is a priority for ABELMed Inc. and ISO 13485:2003 Certification is just one of several ways that we work to ensure patient safety. Our quality system processes including rigorous, automated and manual QA testing protocols ensure we develop the highest quality products and services.
1 Quality Systems ISO 13485:2003 information and guidance documents from Health Canada can be found at: