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at644
@at644
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Joined: Sep 1, 2025
Last seen: May 3, 2026
Topics: 3 / Replies: 71
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RE: Project Management Information Systems

Users benefit from training in information systems, including software tools, which help them use it more effectively and efficiently. I do not have e...

6 months ago
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RE: Project Management and Design Controls

Project management varies across companies, reflecting differences in organizational behavior, value delivery systems, and infrastructure. Incorporati...

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

The company’s organizational structure can affect the project manager’s responsibilities. The project manager has more power than a functional manager...

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

A project manager can evaluate the project outcomes and monitor its products. Results of the project can be assessed for their benefits or value, espe...

6 months ago
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RE: Pre-market Approval (PMA) vs. 510(k)

A company may or may not pursue a pathway based on its capabilities or motives. Challenges can arise during the process of submitting a 510(k) or PMA....

6 months ago
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RE: Managing Scope and Stakeholder Expectations

A project manager who understands value will help them navigate the stakeholder expectations and stay within scope. Value delivery can improve the tea...

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

I agree with Jacob that regulatory or quality engineering are appropriate fields for a project manager to have experience in. Furthermore, a backgroun...

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

There is emphasis on interpersonal skills for project managers. As cra24 explained, a well-rounded project team has members with diverse backgrounds a...

6 months ago
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RE: Risk Management in the Manufacturing Process

Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likeliho...

8 months ago
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RE: Are We Over-Relying on FMEAs?

FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to ...

8 months ago
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RE: Residual risk during device development

Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team ...

8 months ago
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RE: Efficiency or Compliance?

Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope managemen...

9 months ago
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Replies: 7
Views: 1061
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RE: Design Transfers to Contract Manufacturers

Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer mus...

9 months ago
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