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mh746
@mh746
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Joined: Jan 24, 2025
Last seen: Mar 30, 2025
Topics: 11 / Replies: 31
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RE: Cost Estimation Challenges in Planning Phase

Cost estimation in medical device projects is challenging because many factors can change unexpectedly. A major issue is estimating costs before fully...

1 month ago
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RE: Benefits associated with Work Breakdown Structure

A Work Breakdown Structure (WBS) simplifies project planning by breaking a large, complex project into smaller, more manageable parts. This allows tea...

1 month ago
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RE: Role of initiation process in medical device project

The initiation phase in medical device projects is crucial because it lays the foundation for everything that follows. Key inputs like feasibility stu...

1 month ago
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RE: Value of Design Controls

Strict design controls are essential for ensuring safety and regulatory compliance, but they don’t have to stifle innovation. Companies can maintain f...

1 month ago
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RE: Role of Enterprise Environmental Factors in Project Initiation

An organization’s culture and resources directly impact project execution by shaping how teams collaborate and make decisions. A company with a hierar...

1 month ago
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RE: Risk Mitigation and Continuous Improvement

A key way to strengthen verification strategies after a failure is to establish a structured feedback loop where testing outcomes directly inform futu...

2 months ago
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RE: Design Input Document (DID) and Design Specification Document (DSD)

Keeping the Design Input Document (DID) and Design Specification Document (DSD) separate helps ensure a smooth development process by allowing flexibi...

2 months ago
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RE: Managing Scope and Stakeholder Expectations

A key strategy for managing stakeholder expectations while staying within the project’s scope is to establish clear project boundaries from the beginn...

2 months ago
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RE: Humanitarian Device Exemption

One major challenge with the Humanitarian Device Exemption (HDE) is the balance between access and safety. Since these devices don’t have to meet the ...

2 months ago
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