Structure comprehensive software lifecycle processes ensuring safety classification compliance and systematic development.
How do I determine the correct IEC 62304 software classification for my device?
What level of detail should I include for SOUP components in my plan?
How do I handle agile development within the IEC 62304 framework?
What documentation must be maintained throughout the software lifecycle?
How do I manage software changes after market release?
What verification activities are required for different software classifications?