New Whitepaper: Agile and High Assurance


For those who have been following the High Assurance and Regulated Environments series, I am pleased to announce the completion and publication of the whitepaper: Agile Software Development with Verification and Validation in High Assurance and Regulated Environments.

(Click on the image below to download a copy.)

This document was the result of a year-long research project and collaboration with a number of other experts in the field. I’d like to particularly thank Craig Langenfeld of Rally, who persistently moved the project forward and built all the examples, and Michael Messier, VP for Software R&D at Omnyx, who provided in-depth domain expertise and helpful reviews along the way.

4 thoughts on “New Whitepaper: Agile and High Assurance

  1. Dean, Craig, Yvonne;
    Great job on the white paper and supporting research. One key area the white paper did not address is the content required for premarket submissions (510k, PMA, IDE, Clinical evaluation) for software medical devices. Much of the information required for these submissions is collected as output from the development process. Too often I find my FDA software company clients performing retroactive steps to document this content for their regulatory submissions.

    • Thanks Steve,
      Could you perhaps highlight the nature of the content required that is not addressed by the artifacts and traceability mechanisms highlighted in the whitecap? In other words, what specific gaps do you see?

      I’m sure this would help others understand how to augment the methods that we described.

      • Sure Dean, I agree on more specifics,
        In addition to the FDA’s Quality System Regulation specific to SW (21 CFR820.30); a medical device software MFG is required to make premarket submissions that has it’s owns set of (regulatory) requirements depending on the device’s classification, complexity, and risk. It is important to realize the requirements, resources, and costs associated with device submissions that have clear, concise, and complete software documentation.

        In the FDA’s Guidance for the Content of Premarket Submissions for Software Constrained in Medical Devices as a general plus any device specific recommendations, i.e., FDA Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, require software artifacts and traceability to support a determination by the FDA that the software is safe and effective.

        The first hurdle is for the SW MFG to determine the device’s SW level of concern and device classification. The output from the process to determine the level of concern (FDA) and software safety classification (IEC 62304) establishes early on, the required software artifacts and level of documentation required for the premarket submission (including any device specific requirements).

        Although risk management was mentioned, risk analysis, risk evaluation, and risk control traceability is required. This may pose additional discussion on how quality management, risk management and software development processes are integrated, but risk management must be included in the SW development process at the right times (good news is that device risk management is ongoing and its iterations can be integrated into an Agile process. Careful planning by the SW dev team is needed to have the information and documentation required for adequate risk management and traceability to design controls.

        Detailed design documentation. the software architecture, state diagrams, flow charts, methods, algorithms and technology must be submitted. Much of this information is basic, but the SW development process needs to provide these outputs.

        Software development environment and SW development processes. The FDA requires documented and controlled process. We can’t overlook the obvious, but a good software development plan is needed to document the processes, development environments and project deliverables required.

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