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Problem Resolution

Another regulatory requirement is having a problem resolution process. We'll briefly take a look what that means.

How do you need to handle and document problems to be IEC 62304 - compliant?

We'll be covering:
  • What tools could you use (GitHub / GitLab, Jira, Google Sheets)?
  • How do you do a severity assessment of problems?
  • How do you fulfil the requirement of a root cause analysis?