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dk555
@dk555
Trusted Member
Joined: Sep 5, 2024
Last seen: Mar 29, 2025
Topics: 1 / Replies: 69
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RE: Effective Scheduling in Medical Device Development

To build on the early start and early finish dates, these dates can also provide project teams with "buffer zones" that can help to absorb delays or r...

1 month ago
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RE: Works of a project manager and a program manager?

Project and program managers also have a big difference in decision-making and risk management. Project managers focus on mitigating risks within a si...

2 months ago
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RE: Managing Scope and Stakeholder Expectations

Risk assessment and scenario planning could also serve as additional tools for stakeholder alignment. When verification failures occur, project teams ...

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

Great points! I also think that a hybrid approach could be a strong alternative that could maintain the clarity of separate documents while still impr...

2 months ago
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RE: Managing Design Change Requests Effectively Without Disrupting Development

I would like to expand on risk assessment during the change control process. Changes, by nature, can introduce new risks. This comes either via produc...

2 months ago
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RE: Test Method Validation

TMV is crucial for ensuring reproducibility and consistency not just during product development, but also across different production batches and loca...

2 months ago
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RE: How Frequent Design Reviews Can Improve Medical Device Quality and Reduce Failures

I would like to add that companies can further enhance the effectiveness of these reviews by adding in simulation and prototyping early in the process...

2 months ago
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RE: Handling Conflicts Among Team Members Effectively

All of these responses provide valuable insights into conflict resolution strategies. I'd like to expand on the importance of emotional intelligence (...

2 months ago
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RE: Seeking Insights on working as a Project Manager in the Medical Device Field

Hey Mirna, I think it's great that you have a specific career path in mind for your future. While I am not a project manager myself, I have a simila...

2 months ago
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RE: The Role of Regulatory Strategy in Combination Product Development

I agree that balancing in-house and external expertise can be beneficial, however, I would also like to emphasize the product development timeline and...

2 months ago
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RE: Role of Project Management in Medical Device Development

The challenges in managing medical device projects are definitely multifaceted, but in my opinion, one of the largest challenges lies in balancing cro...

2 months ago
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RE: Role of risk management in medical device projects

I'd like to add that one of the compounding challenges in this area is how regulatory risks can cascade into other risk categories, such as financial ...

2 months ago
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RE: Balancing Stakeholder and Customer Values

I agree that where the value goes depends case-by-case. I would also add that a project manager could/should also weigh long vs short-term impacts of ...

2 months ago
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RE: Company Insurance

As a business owner, having a detailed and structured plan in place for potential emergencies is essential to ensure the continuity of operations and ...

4 months ago
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RE: Conflict Resolution in Contract Law

In medical device consulting agreements, proactive conflict resolution strategies often focus on creating efficient and equitable processes. Incorpora...

4 months ago
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