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 critical role. Investors provide the funding and ...

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 of the design control process can be made. Before t...

Balancing risk and reward is one of the biggest challenges in risk management. While minimizing risk is necessary, trying to eliminate every possible risk can slow down development and increase costs....

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 because it gives a project manager flexibility. A proj...

Estimation failures in the planning phase of a medical device project can severely threaten the success of a project because cost, project timeline, and regulatory compliance are connected. If tasks i...

Avoidance is most easily incorporated during the product design phase. During the design phase the device is still conceptual, and hazards can be eliminated before they are built into the product. In ...

I agree that it is important to remain impartial when dealing with conflicts between team members. However, this becomes much more challenging when the project manager and a team member are the ones e...

Detailed planning should definitely take place before the planning phase of the project management process concludes. However, I think it’s important that the project management plan should not be vie...

Hi everyone! My name is Sarah Gildea, and I am pursuing a graduate certificate in Biomedical Device Development at NJIT. I look forward to connecting with all of you! Here is my LinkedIn:

While I do not have direct experience in the medical device industry, I have experience working at a local retail store whose structure closely resembled a matrix organization. As a supervisor and dep...

After completing the simulation, I do not believe changing the Design Specification Document (DSD) is necessary to resolve the failed verification test. When I asked if there is a minimum or maximum t...

While I don’t have any formal industry experience, I do have experience following the design control process for my undergraduate capstone process. Over the course of one year, my team was developing ...

I also have wondered why the design inputs and specifications are split into two documents. The Design Input Document falls under the planning phase of the PDCA cycle and focuses on user needs and int...

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 the design is completed significantly increases the ...

It is extremely important to have justified specifications for each design input when following design controls for medical devices. To determine specification, you would look at each design input ind...