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...

Performing project quality assurance or monitoring & controlling the project execution are significant for its success. Preventive actions, such a...

Verification includes testing to determine if the inputs match the outputs. Validation, on the other hand, assesses whether the inputs meet the user's...

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 o...

Testing results should be communicated to stakeholders or senior management, and the project manager will need their approval to proceed with further ...

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 th...

Including costs and resources in the risk management analysis can lower project estimates. Finding alternatives to different resources to mitigate ris...

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-...

An organization running multiple projects will have many tasks that should ideally be organized, and there are different methods for planning them. De...

Poor execution and late regulatory integration are both common pitfalls for medical device developers. Startups are likely to design medical devices w...

Regulatory authorities, third-party organizations, or internal auditors will issue their findings, including identified non-compliances or non-conform...

Fair treatment and engagement with team members are part of stewardship, which embodies a broader commitment to the organization and its stakeholders....

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 equiv...

Different organizational structures have both pros and cons. While these structures affect projects and their outcomes, they are also influenced by ot...

Soft skills can be used to align business needs with customer satisfaction. Empathy and active listening help when dealing with customers, especially ...