Can the development of a Software Medical Device be Agile ?

The question I want to discuss here is to know if a Software MD (Medical Device) can be developed in an Agile way. Or is it condemned to a Waterfall-old-style method ?

To apply Agile on a Software Medical Device of class B or C (for Europe - IEC 62304) or Major or Moderate (for USA - FDA), several problems appear.

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