Procedure for the Software Life Cycle

Each medical device software must be developt under the IEC 62304:2006 Medical device software — Software life cycle processes. In this standard is described how software life cycle procedure must be. 

Our ISO 13485:2016 documentation toolkit covers only documented procedures and requirements directly asked in the ISO 13485:2015 standard. This documentation covers the Quality management system that is applicable for all manufacturers of medical devices. 

Please understand that the range of medical products ranging from spoons for giving antibiotics to the artifitial heart. It is not possible that one documentation toolkit have all documentation from technical standards.