IEC 62304 compliance with codeBeamer ALM
Customized development support tool for Medical Software Development
Intland presenting at AgileMed 2014 – 19th February Munich
Intland developed a project template for Medical Devices Producers, to support the embedded software development process by customized ALM functionality.
IEC 62304 standard requirements can be fully cover by codeBeamer medical ALM.
codeBeamer Medical ALM contains specific medical trackers for requirements management, specific risk tracker and risk management workflow; furthermore a medical wiki, with all elements that are required by the IEC 62304 standard including the Traceability Matrix. The Medical Document Management has been equipped with template documents, process descriptions based on the codeBeamer ALM. It ensures base lining and versioning of all artifacts, and provides full traceability on development and IT operations. Test and Quality assurance processes are integrated and managed across the development lifecycle. All agile functionality of codeBeamer (Agile Planning Board, Kanban board) ALM is available in this customized medical project template.
By using a specific medical ALM software the following benefits can be achieved:
- Reduce effort to customize ALM tools to be compliant with standards (e.g. IEC62304, ISO standards for medical, and FDA regulations),
- Import domain knowledge therefore gain quicker roll out,
- Implement agile practice to increase efficiency and reduce time to market,
- Keep flexibility by customizable projects and workflows to match with internal rules and processes.
Click and read more about codeBeamer ALM for Medical Device Development.