Each year on 14 October, we celebrate #WorldStandardsDay, which is a means of paying tribute to the collaborative efforts of thousands of experts worldwide who develop voluntary technical agreements that are published as International Standards.
We at Innovation are proud to say that we are compliant to the following ISO standards:
• ISO 9001:2015 - Quality management systems — Requirements
• ISO/IEC 27001:2013 - Information technology — Security techniques — Information security management systems — Requirements
• IEC 62304:2006 – Medical Device Software – Software Lifecycle processes
• IEC 60601-2-47:2012 - Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
• IEC 60601-6:2010 - General requirements for safety – Collateral Standard: Usability
• ISO 13485:2016 – Medical Devices - Quality management systems — Requirements for regulatory purposes
• IEC/TR 80002-1:2009 - Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
• EN ISO 14971:2019 - Medical devices - Application of Risk Management to Medical Devices
Standards make our work easier and our @ECGAlert & @Glyco software better!