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mjc22
@mjc22
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Joined: Sep 4, 2024
Last seen: Mar 16, 2025
Topics: 0 / Replies: 58
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RE: Enhancing Quality Assurance: Lessons from the DePuy ASR Hip Recall

Improving quality assurance processes in the medical device industry is essential to preventing failures like the DePuy ASR hip implant recall. One of...

2 weeks ago
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RE: Optimizing Information Distribution

In my opinion, it is important to find a balance between time spent on communication and working on projects. Communication is key to the success of a...

2 weeks ago
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RE: Planning Techniques

Determining when the planning phase is complete without knowing exactly how a project will unfold is a challenge that project managers face. One way t...

2 weeks ago
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RE: Considerations of Verification Protocols

To ensure that a verification protocol is rigorous and detailed enough, project teams must focus on clarity, thoroughness, and traceability throughout...

3 weeks ago
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RE: Email Communication

Project managers can efficiently manage their inboxes by implementing strategies to prioritize and organize emails effectively. One common approach is...

3 weeks ago
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RE: Planning and Executing in Project Management

In biomedical engineering project management, the planning and execution phases are critical to ensuring the success of a project. Effective planning ...

3 weeks ago
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RE: Different Types of Risks in a Project

In my experience, the most present risk in nearly every project is usually schedule risk. Deadlines are often affected by unexpected delays, resource ...

1 month ago
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RE: Cost Estimation Challenges in Planning Phase

Cost estimation is a major challenge, especially in highly regulated industries like medical devices where unexpected compliance hurdles or clinical t...

1 month ago
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RE: Identifying the Critical Path – Preventing Project Delays

I would agree that many teams struggle with identifying which tasks are truly critical versus those with flexibility, leading to wasted resources and ...

1 month ago
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RE: Value of Design Controls

Balancing design controls with flexibility needed for innovation is essential in regulated industries like medical devices. To achieve this, companies...

1 month ago
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RE: Making connections between people and schools

Hi everyone, my name is Megan and I am currently pursuing my MS in BME at NJIT. Connect with me below: linkedin.com/in/megan-crawford-180324294

1 month ago
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RE: Benefits associated with Work Breakdown Structure

A work breakdown structure (WBS) facilitates better project planning by providing a clear definition of the project’s scope and breaking it down into ...

1 month ago
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RE: Verification Failures and Adjusting Test Conditions

In order to create a robust final product, it is important to understand the worst-case scenario outcomes. If a product undergoes rigorous testing of ...

2 months ago
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RE: The Importance of the Design History File (DHF) in Regulatory Compliance

I completely agree with your perspective that the Design History File (DHF) should be treated as an active part of the product development process rat...

2 months ago
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RE: Risk Mitigation and Continuous Improvement

The verification failure shows the importance of integrating a strong risk management framework and focusing on continuous improvement in medical devi...

2 months ago
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