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Krish
@krish
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Joined: Aug 29, 2025
Last seen: Apr 10, 2026
Topics: 0 / Replies: 66
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RE: Navigating Design History and Project Delivery

In medical device development, the PM's responsibilities definitely expand beyond traditional management, but I would not say they shift completely aw...

2 months ago
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RE: How to navigate errors as a PM

For a project to return to a previously "completed" phase in the PDCA cycle, a PM needs strong skills in risk assessment, change management, and stake...

2 months ago
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RE: Certifications vs Degrees for Project Management

As you had said, Jacob, I think the longitudinal ROI in Project Management for degrees and certifications serves different, yet complementary function...

2 months ago
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RE: Failed Verification Testing

Your example certainly highlights how verification failures often shed light on component selection and manufacturability issues rather than about the...

2 months ago
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RE: Design Change Requests

An effective way to avoid such a situation would be to do integrate "version control checks" into the design change request process. For example, by m...

2 months ago
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RE: Business and customer satisfaction in project management

Effective project managers can skillfully align business needs and customer satisfaction by rectifying organizational strategy and customer value. Typ...

2 months ago
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RE: Developmental Life Cycles

I think predictive development life cycles work most aptly in highly regulated industries, such as medical devices, when requirements and regulatory p...

2 months ago
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RE: Project Managers utilization of PDCA and other structured processes

Design reviews and design change requests are most integral during the Check and Act phases. During the Check phase, verification activities are perfo...

2 months ago
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RE: Project Management and Design Controls

When design controls and project management are segmented, gaps may be created that could affect verification, validation, and design reviews. If sche...

2 months ago
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RE: Product vs. Project Life Cycle Relationships

The relationship between the project and the product life cycle is that the project life cycle is embedded within the product life cycle. The product ...

3 months ago
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RE: PERT and CPM as managerial techniques in the Medical Devices Industry

I have not formally worked in industry either, but I do have some knowledge of PERT and CPM in the medical devices industry, gained through conversati...

3 months ago
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RE: Project Manager role in Post Market Surveillance

First, I certainly agree that a PM's role goes past market release to monitoring outcomes and project value. For post-market management, the PM's main...

3 months ago
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RE: The Cross Disciplinary Skills Needed in a Project Manager

The most effective medical device PM would be a cross between a specialist and a generalist. Due to the cross-functional nature of MDD projects, a PM'...

3 months ago
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RE: Team Conflict with Project Manager

I certainly agree that most interpersonal conflict may arise from misalignment rather than dispositional differences. Misalignment may stem from expec...

3 months ago
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RE: How can a project manager excel in the Biomedical field?

Project management is certainly a very demanding role, uniquely situated at the crossroads of biomedicine, regulation, and team coordination. Given it...

3 months ago
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