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Forum Replies Created

RE: Scope Management in Biomedical Devices

Adding on to the others, COVID is a prime example of where agile scope management was applied. As more information came out, project scopes most likely increased. One example of this is a company call...

In forum Project Management Knowledge Areas

10 months ago
RE: Scope Management and the Role of the WBS in Project Clarity

WBS should be closely aligned with a company's risk management planning. Different deliverables like the change history are effective in a WBS, but incorporating a risk-perspective into the WBS as wel...

In forum Project Management Knowledge Areas

10 months ago
RE: Critical Path, PERT, and Managing Time Under Uncertainty

Adding on to what was said, an effective way to manage time compression while mitigating risk if employing a scenario-based method that can evaluate the trade-offs faced when pressed for time. A proje...

In forum Project Management Knowledge Areas

10 months ago
RE: The Impact of Earned Value Management (EVM) on Project Budgeting

As you mentioned, EVM is a good tool for identifying if a project is behind schedule by using EV and PV. One additional benefit of EVM is its ability to detect scope creep before it happens. Projects ...

In forum Project Management Process and Medical Device Development

10 months ago
RE: Why Capturing Lessons Learned Matters

Capturing lessons learned by using a slideshow presentation or using software like sharepoint is a good idea, but making these efforts to capture the project lessons without working off of them could ...

In forum Project Management Process and Medical Device Development

10 months ago
RE: Making Design Reviews Work in Medical Devices

The main key aspects of the preparation for a design review were covered previously, however one critical step for preparation is engaging with stakeholders prior to the design review meetings. Stakeh...

In forum Project Management Process and Medical Device Development

10 months ago
RE: How do the FDA manage

For many products, companies are required to follow GLP and other good practices as mentioned previously. These good practice rules give companies an outline on standard protocols to follow when it co...

In forum Project Management Process and Medical Device Development

10 months ago
RE: Project Initiation

One way to prepare for challenges in the product development process early is to organize review meetings with team leaders from cross-functional teams. When project members from different teams, for ...

In forum Project Management Process and Medical Device Development

10 months ago
RE: Managing Challenges in Metrics

Making sure that relevant metrics are collected efficiently and correctly are indeed an important step in the project process. One way to make sure the metrics that are collected are relevant with the...

In forum Project Management Process and Medical Device Development

10 months ago
RE: Sequence of the PM Process

Cross-functional teams are essential to many projects, and omitting a sequence of activities can significantly impact their purpose. The purpose of these teams is to allocate project resource effectiv...

In forum Project Management Process and Medical Device Development

11 months ago
RE: Execution phase

One way to make sure that all project documents remain accurate and update is by maintaining and utilizing version control software, along with access control. As mentioned, suppliers and manufacturer...

In forum Project Management Process and Medical Device Development

11 months ago
RE: The Crucial Role of Regulatory Compliance in Medical Device Innovation

An important factor to consider which is equally important as pre-market approval is post-market surveillance of medical devices. A rigorous and well-made pre-market portion of a medical device projec...

In forum Project Management Process and Medical Device Development

11 months ago
RE: Making connections between people and schools

Hello all, My name is Paul and I am a BME masters student at NJIT. Here is my LinkedIn:

In forum Project Management Process and Medical Device Development

11 months ago
RE: Role of Stakeholder Management in Project Success

As mentioned before, a RACI can certainly help decrease the ambiguity associated with the development of a syringe that does not leak and clump. However, a RACI does not directly address the risks tha...

In forum Project Management Process and Medical Device Development

11 months ago
RE: Considerations of Verification Protocols

Designing a risk assessment properly by taking into account all the details that can contribute to risk in a project can help strengthen a verification protocol considerably. Identifying errors or pot...

In forum Project Management Process and Medical Device Development

11 months ago
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