A project manager is leading a project to develop a new medical device. The regulatory requirements are strict and fixed, but the software interface design is uncertain and requires user feedback. Which development approach is MOST appropriate?

Answer options:

Predictive approach for the entire project to ensure compliance.

Agile approach for the entire project to maximize adaptability.

Hybrid approach: Predictive for hardware/regulatory and Agile for the software interface.

Iterative approach to refine requirements for both hardware and software.

How to approach this question

Analyze the characteristics: Fixed/Stable = Predictive. Uncertain/Evolving = Agile. Both present = Hybrid.

C.Hybrid approach: Predictive for hardware/regulatory and Agile for the software interface.✓ Correct

Hybrid methodologies are ideal when a project has mixed characteristics (e.g., tangible industrial components vs. intangible software components).

Assuming 'medical' always means Predictive or 'software' always means Agile without considering the whole picture.

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