Question

A project manager is delivering a medical device software product that must comply with regulatory standards before market release. Midway through execution, the sponsor asks the project manager to confirm that the compliance requirements are actually being met, not just documented. What is the BEST method for the project manager to provide this assurance?

Accepted Answer

Conduct a compliance audit against the applicable regulatory requirements and document the findings

Answer

Review the project charter to confirm that compliance was listed as a project constraint

Answer

Ask each team member to self-attest that their work follows the required standards

Answer

Add a compliance risk to the risk register and assign a contingency reserve