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Question 1 of 30
MediCore Solutions, a medical device manufacturer, is initiating a project to develop a new generation of infusion pumps intended for global distribution. Given the highly regulated nature of medical devices and the requirement to adhere to ISO 13485:2016, the project team recognizes the need for a strong governance framework, aligning with the principles outlined in ISO 21502:2020. Considering the project\'s complexity, the need for cross-functional collaboration, and the importance of regulatory compliance, which of the following approaches would be the MOST effective in establishing a robust governance structure for this project? This governance structure must ensure that the project objectives align with MediCore Solutions\' strategic goals, regulatory requirements, and quality management system. It must also address risk management, compliance, and stakeholder engagement throughout the project lifecycle. The new infusion pump must meet stringent safety and performance criteria to ensure patient safety and regulatory approval in various global markets.
Establish a project governance committee composed of cross-functional representatives (regulatory affairs, quality assurance, engineering, clinical affairs) with a defined charter outlining their authority, decision-making process, and escalation paths.
Assign the project manager full authority for all project-related decisions, relying on their expertise to ensure compliance and alignment with organizational objectives.
Conduct informal consultations with key stakeholders as needed, documenting decisions in meeting minutes but without a formal governance framework.
Outsource the project governance function to a specialized consulting firm with expertise in medical device regulations and project management.