PMP · Question 58 · Task 7: Plan and manage quality of products/deliverables
A project manager is implementing quality management for a medical device development project that must meet FDA regulatory standards. The project team has established quality processes, but recent testing has revealed several defects that could impact regulatory approval. The defects are not critical safety issues but do affect product performance. What should the project manager do FIRST?
Answer options:
Continue with the current quality processes since the defects are not safety-critical
Analyze the root causes of the defects to determine if quality process improvements are needed
Increase testing frequency to catch defects earlier in the development process
Report the defects to the FDA as part of the regulatory compliance process
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