A project to develop a new medical device has fixed regulatory requirements that must be planned upfront. However, the user interface for the device software needs to be developed with flexibility to incorporate feedback from clinical trials. Which project management approach is MOST suitable for this scenario?
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A
A purely Agile approach to allow for maximum flexibility.
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B
A traditional Waterfall approach to ensure all regulatory requirements are met sequentially.
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C
A hybrid approach, using a predictive model for the regulatory aspects and an adaptive model for the software interface development.
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D
A Lean methodology focused exclusively on eliminating waste in the development process.