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ma2726
@ma2726
Estimable Member
Joined: Jan 18, 2024
Last seen: Nov 27, 2024
Topics: 13 / Replies: 63
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RE: Examples of when Design Validation is Not Required

In some cases, validation in the development of medical devices may be superfluous, especially when the consumer need is clear without the need for si...

1 year ago
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RE: Verification & Validation NDAs

Building on the concept of non-disclosure agreements (NDAs) and their significance in protecting a company's secret information, it is clear that thei...

1 year ago
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RE: Collaborative Research in Academia and Industry

Balancing academia's open research values with the industry's demand for safe data in medical device creation requires a sophisticated strategy. Estab...

1 year ago
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RE: Leaders of Change Control

Indeed, change control is critical in the medical device industry due to its direct impact on patient safety. In larger firms, dedicated change contro...

1 year ago
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RE: Strategies to Counteract Negative Schedule Variance

You've highlighted an important facet of project management, particularly when dealing with negative schedule variance (SV). Identifying the core reas...

1 year ago
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RE: Changes to Products in Production

Even after a project is completed and sent into production, the project team's engagement does not necessarily cease there. While they provide paperwo...

1 year ago
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RE: Instances of Multiple PMs

Managing projects in the medical device industry entails a wide range of responsibilities, and the idea of having many project managers to help allevi...

1 year ago
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RE: Compromises in Conflict

When compromise is required due to opposing viewpoints and power imbalances, it is critical to promote open communication, mutual understanding, and a...

1 year ago
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RE: Monitoring and Controlling Planned Value

When regulating the anticipated value in the monitoring and controlling phase of a project, multiple aspects need to be taken into account. Experience...

1 year ago
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RE: Determining relationships between tasks

Open communication and collaboration within the project team are essential for gathering feedback from all team members without wasting time on Gantt ...

1 year ago
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RE: How poor planning affects a project

Considering the importance of project beginning and the consequences of inadequate planning, I agree with the views expressed by others about its cruc...

1 year ago
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RE: Project Charter

Project charters, especially in front-end research and development, are difficult to secure, especially when financial models fail to win sponsor supp...

1 year ago
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RE: Keeping Finances a Secret from the PM

In our recent lectures, we discussed project managers (PMs) but not much of project finances, which is interesting. Adding to the excellent points, re...

1 year ago
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RE: EF and LF in Medical Device Development

Late Finish Date: Example: Development of an Implantable Cardiac Defibrillator (ICD) Implantable cardiac defibrillators are complex medical dev...

1 year ago
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