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. ISO 13485 is a prerequisite to receiving a Class II Medical Device Licence.
Since patient management software has the ability to affect the diagnosis or treatment of a patient, it fits the definition of a medical device and must comply with the requirements of the Medical Devices Regulations.2 ABEL has held a Medical Device Establishment Licence for Class I Medical Devices since 2008 and has applied for the Class II Medical Device licence for our latest version, ABELMed EHR-EMR/PM v11.3
Offering our customers both high performance and safe software is a priority for ABELMed Inc. and ISO 13485:2003 Certification and Class II Medical Device licensing are just two of several ways that we work to ensure patient safety. Our rigorous, automated and manual QA testing protocols ensure that the product is robust and issues are resolved prior to its deployment.
1 Quality Systems ISO 13485:2003 information and guidance documents from Health Canada can be found at:
2 Information from Health Canada on Medical Device licence can be found at:
3 The latest information about ABEL’s Class II Medical Device licence can be found at: