How to incorporate Agile-Scrum in a Software-As-A-Medical device environment? Some ideas suggested:

  1. Follow agile-scrum within the overall release cycle regularly: Example - Say you have releases every 6 months. Plan to run 2-week sprints to make progress towards the goals. Make incremental progress towards the overall stories.
  2. Get customer feedback using informal and formal processes: Use internal experts (product specialists) for informal feedback. Create a formative study with a limited set of end-user/customers and see feedback every month or 2 or 3. External feedback can also be done informally by demoing or providing sandboxes to customers.

Agile Scrum in a Software-As-A-Medical-Device-Environment

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