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FDA and other regulatory agencies fundamentally want to see that your product has safety in mind. To do so, they require complete traceability through the hardware and software. There is even a fairly new standard, IEC 62304, adopted worldwide that is wholly focused on software traceability from requirements through architecture to tests.

Medical devices companies are going primarily agile to respond to change and effectively manage technical complexity by collaboratively building solutions with their partners and customers to ultimately deliver what the customer wants before the competition does.

demo the new functionality created after each iteration to your customers, using web-based meets. Using these tools enables you to get immediate feedback from your customers throughout the project. Continuous customer feedback reduces the risk of building the wrong solution. The fact is in most cases you can’t make the release cycle more frequent since it includes giving tests to regulatory agencies. This is a tedious process that makes sure the device is safe. Doing the whole release cycle more frequently can be way too time consuming.

The guidance covers several key topics such as documentation, evolutionary design and architecture, traceability, verification and validation, managing changes and “done” criteria. the document has become a must-have reference document for every professional implementing Agile to develop medical devices software. It focuses on providing the following:

we operate in a highly regulated environment so there are a number of additional quality and regulatory steps that must be completed before we can accept a "user story"— that scenario written in the business language of the user that captures what he or she wants to achieve. Therefore, our "definition of done" — that is, the list of activities that add value to the product such as unit tests, code coverage, and code reviews — turned out to be lengthy.