I think that managers and stakeholders are both important to a project, however when it comes to completing a project promptly, managers play the more...

Being prepared before a design review meeting is important to ensure the meeting runs smoothly and a decision about moving forward to the next phase o...

Balancing risk and reward is one of the biggest challenges in risk management. While minimizing risk is necessary, trying to eliminate every possible ...

Slack is the amount of time a task can be delayed without delaying the project completion date. As others have stated, project slack is important beca...

Estimation failures in the planning phase of a medical device project can severely threaten the success of a project because cost, project timeline, a...

Avoidance is most easily incorporated during the product design phase. During the design phase the device is still conceptual, and hazards can be elim...

I agree that it is important to remain impartial when dealing with conflicts between team members. However, this becomes much more challenging when th...

Detailed planning should definitely take place before the planning phase of the project management process concludes. However, I think it’s important ...

Hi everyone! My name is Sarah Gildea, and I am pursuing a graduate certificate in Biomedical Device Development at NJIT. I look forward to connectin...

While I do not have direct experience in the medical device industry, I have experience working at a local retail store whose structure closely resemb...

After completing the simulation, I do not believe changing the Design Specification Document (DSD) is necessary to resolve the failed verification tes...

While I don’t have any formal industry experience, I do have experience following the design control process for my undergraduate capstone process. Ov...

I also have wondered why the design inputs and specifications are split into two documents. The Design Input Document falls under the planning phase o...

I agree that it is crucial to treat a DHF as a living document that is built throughout the project rather than assembled at the end. Waiting until th...

It is extremely important to have justified specifications for each design input when following design controls for medical devices. To determine spec...