The engineering of medical devices requires compliance with intentional standards. Medical devices often contain software-controlled applications, the failure of which to function correctly could result in death or serious injury to the patient treated by them. Despite this increased danger, medical software standards still continue to reflect only the rigor of low-risk applications with potentially fatal consequences. Software development is an integrated part of the production of medical devices, therefore traceability, and software quality assurance is ranked as a top priority for manufacturers of medical devices. Processes along the application development lifecycle must be compliant with IEC 62304 and exceed those required standards. ALM applications implemented in the medical field must be able to support standardized procedures, based on the required standards. Intland Software implemented the Medical Project solution, as a customized template to not only meets those required standards but to be adaptable to your extended requirements delivered with codeBeamer ALM and developed with the support of medical domain experts.
Three main highlights of the customized template
- Traceability matrix, works as a wiki plug-in that enables the visualization of all dependences among any requirements, risk and test cases trackers.
- Risk tracker – tracker and implemented risk management workflow supports the fulfillment of systematic risk management process execution and monitoring along the whole development lifecycle.
- Medical wiki – is a knowledge base according to IEC62304 equipped with process descriptions, document templates, risk-requirements management rules, test and quality assurance process definition, and description of how codeBeamer Medical Project supported each elements of the standard requirements.
For further and detailed information, please send your request to download the Medical Project brochure or request a web demo.