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IEC 62304 compliance with codeBeamer ALM

blog-140108codeBeamer ALM is a highly customizable development tool for healthcare IT & medical device software development. Intland’s Medical IEC 62304 & ISO 14971 Template has been preconfigured for compliance, while the scalable & flexible platform can be easily adapted to any development scenarion.

To support producers of medical devices and innovative healthcare technology products, Intland Software has built a preconfigured medical project template. The requirements of international standards IEC 62304 and ISO 14971 are fully covered by codeBeamer Medical ALM.

The template contains trackers for medical requirements management, specific risk trackers, and risk management workflows. A medical wiki is included, containing all the elements that are required by IEC 62304 and ISO 14971. The Traceability Browser helps stay on top of relations between artifacts. codeBeamer's medical Document Management feature set comes equipped with template documents and process descriptions.



The system supports the baselining and versioning of all artifacts, and provides full traceability on development and IT operations/DevOps. Testing and Quality Assurance processes are integrated and managed across the development lifecycle. The customized medical template also offers Agile features so as to support compliance in an Agile development environment.

Use an ALM software specifically built for medical development for the following benefits:

  • Reduce effort in customization & audit preparation work for achieving compliance (e.g. IEC 62304, ISO 14971, FDA regulations, etc)
  • Import domain knowledge out of the box to accelerate rollout
  • Implement Agile practices to increase efficiency and reduce time to market while maintainign compliance
  • Keep flexibility by customizing projects, artifacts, and workflows to match with internal processes and external regulations.

Click and read more about codeBeamer ALM for Medical Device Development.

  Setting up Medical Device Software Development Projects in Compliance with  IEC 62304 and ISO 14971 (in collaboration with adesso AG)

Intland’s Medical IEC 62304 & ISO 14971 Template brochure

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