Maintaining detailed project documentation is critical to ensuring a smooth execution phase. A well-organized log of risks, actions, issues, and decisions (RAID log) helps project managers track key a...

Altering or omitting sequence activities can lead to significant project risks, including scope creep and timeline disruptions. If tasks are not performed in the correct order, dependencies may be ove...

The project initiation phase is crucial in setting the foundation for success, but it also presents several challenges. One major challenge is securing stakeholder alignment because of differing prior...

Task scheduling is essential for keeping a project on track, but a major challenge is dealing with unexpected delays. One way to address this is by incorporating buffer time within critical tasks to a...

Scope verification and design controls verification share some similarities but present unique challenges due to their different focuses. Scope verification ensures that all project deliverables align...

Design Transfer Project Managers and R&D Project Managers play crucial but distinct roles, each facing unique challenges. The R&D Project Manager focuses on innovation, feasibility, and ensuri...

In practice, the scale, time required, and procedures differ considerably among Non-essential Design Changes, Design Change Numbers, and Engineering Change Orders (ECOs). Non-essential Design Changes ...

Keeping up with regulatory trends is an evolving process that requires constant engagement with industry news, conferences, and professional networks. In my experience, staying informed involves subsc...

The debate over certification validity often comes down to what specific skills and frameworks you need in your career. Google PMP, is a relatively new credential that emphasizes practical, agile, and...

A WBS not only breaks down the total scope of work into manageable tasks but also offers flexibility and adaptability in project planning. By decomposing the project into work packages, it becomes eas...

Scope management, time, and cost management are deeply interconnected, especially in complex projects like medical device development. When scope changes, it forces a reevaluation of the timeline and ...

In the initiation phase of medical device project management, key inputs such as the Project Charter, feasibility studies, regulatory landscape assessments, and stakeholder analyses are critical. The ...

During verification testing, it is quite common to encounter unanticipated issues (like adhesive failure in water) that drive budget increases for additional experiments. One way to mitigate this is t...

I believe the differences between project managers and program managers extend into both technical focus and soft skills. Project managers concentrate on the detailed execution of individual projects ...

When determining the correct product code and regulation number, I think it's important to develop a detailed comparison. This tool helps align your device’s key attributes (such as intended use, mate...