Estimation failures during the planning phase can threaten the project's success, as the project is more likely to have a higher burn rate, increasing the risk of running out of budget before project ...

Performing project quality assurance or monitoring & controlling the project execution are significant for its success. Preventive actions, such as obtaining the proper document signatures and ret...

Verification includes testing to determine if the inputs match the outputs. Validation, on the other hand, assesses whether the inputs meet the user's needs and whether the device does what it’s suppo...

Someone with a science degree can also become a project manager. If they have additional work experience, they can be attractive to a medical device organization, especially if they have product lines...

Testing results should be communicated to stakeholders or senior management, and the project manager will need their approval to proceed with further action. Approaching a preliminary test includes id...

Early-stage risk assessments are less expensive than addressing the risks as they arise. Taking risks should not come at the expense of safety, and their significance depends on their severity and pro...

Including costs and resources in the risk management analysis can lower project estimates. Finding alternatives to different resources to mitigate risk can increase project success. Having a vendor wh...

I had a lab research project that followed a finish-to-start mode, where each task could not begin until the previous task was completed. A finish-to-start relationship is common, especially in the la...

An organization running multiple projects will have many tasks that should ideally be organized, and there are different methods for planning them. Depending on the organization's level of project man...

Poor execution and late regulatory integration are both common pitfalls for medical device developers. Startups are likely to design medical devices with a strong emphasis on innovation, and risk inte...

Regulatory authorities, third-party organizations, or internal auditors will issue their findings, including identified non-compliances or non-conformances. Not having a written procedure is a failure...

Fair treatment and engagement with team members are part of stewardship, which embodies a broader commitment to the organization and its stakeholders. Project managers should use lessons learned from ...

Another regulatory strategy is the “De Novo” pathway for a 510(k), under which a low- or moderate-risk medical device that lacks a substantially equivalent predicate device can still be classified as ...

Different organizational structures have both pros and cons. While these structures affect projects and their outcomes, they are also influenced by other organizational factors, as others have shared....

Soft skills can be used to align business needs with customer satisfaction. Empathy and active listening help when dealing with customers, especially since the project manager is trying to maintain a ...