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PMP Practice: Determine potential threats to compliance

Question 3 of 6 in Plan and Manage Project Compliance

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Tomáš Kovář-Novotný is managing a project for Tahini Supernova Studios to develop a medical diagnostic device. The project involves hardware design (requiring strict FDA regulatory submissions at defined gates) and companion software (which will be updated continuously post-launch). During planning, the compliance officer emphasizes that FDA submissions require complete documentation packages with locked specifications at three regulatory milestones. Meanwhile, the software team wants to use iterative sprints to incorporate user feedback from clinical trials. The executive sponsor asks Tomáš to recommend an approach that satisfies both regulatory requirements and allows for rapid software evolution. What approach should Tomáš MOST appropriately recommend?
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Correct answer: Implement a hybrid approach where hardware follows predictive phases aligned with FDA gates while software uses iterative cycles with compliance touchpoints at each gate

Explanation

This scenario requires recognizing that different project components have fundamentally different constraints and choosing an approach that honors both. The hardware component faces rigid regulatory gates that require complete documentation packages at defined milestones—this is a classic predictive context where scope must be locked before proceeding. However, the software component benefits from iterative development and can evolve based on user feedback without compromising regulatory compliance. A hybrid approach allows each component to use the methodology that fits its constraints: predictive for hardware (ensuring FDA submission readiness at gates) and agile for software (enabling rapid iteration), while establishing integration points where both streams align for regulatory review. This respects the compliance officer's requirements while giving the software team the flexibility they need. The key insight is that compliance requirements don't automatically mandate a fully predictive approach—they mandate compliance touchpoints, which can be integrated into a hybrid model.

**Why not B:** Adopting a fully predictive approach for both hardware and software would satisfy the FDA documentation requirements but would eliminate the software team's ability to incorporate user feedback from clinical trials. Locking software specifications at the same regulatory gates designed for hardware ignores the fundamentally different nature of software evolution and would undermine the product's quality and responsiveness to real-world clinical use.

**Why not C:** This option inverts the appropriate pairing of methodologies. Hardware construction and physical fabrication cannot be iterated the way software can—agile sprints for hardware prototyping would not align with the reality of manufacturing processes, material procurement, and physical assembly. Meanwhile, applying predictive methodology to software contradicts the team's need to incorporate ongoing clinical trial feedback.

**Why not D:** A fully agile approach with bi-weekly sprints for hardware development is not compatible with FDA regulatory submissions, which require complete, locked documentation packages at specific milestones rather than incremental compliance artifacts. Submitting partial compliance documentation after each sprint does not meet the documentation standards mandated by regulatory agencies for hardware medical devices.

Key Concept

This question covers Determine potential threats to compliance under Plan and Manage Project Compliance (Business Environment).

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