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sn64
@sn64
Trusted Member
Joined: Sep 6, 2024
Last seen: Feb 10, 2025
Topics: 5 / Replies: 46
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RE: Examples of budget changes due to DSD testing

During verification testing, it is quite common to encounter unanticipated issues (like adhesive failure in water) that drive budget increases for add...

5 days ago
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RE: Works of a project manager and a program manager?

I believe the differences between project managers and program managers extend into both technical focus and soft skills. Project managers concentrate...

5 days ago
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RE: Regulation Number & Product Code for 510k

When determining the correct product code and regulation number, I think it's important to develop a detailed comparison. This tool helps align your d...

5 days ago
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RE: Design and Development Plan

The Design and Development Plan is a foundational blueprint that guides the medical device engineering process. By first setting clear objectives, the...

2 weeks ago
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RE: Design Verification vs Design Validation

Design verification and design validation, though both integral parts of the PDCA cycle, serve distinct roles in medical device development. Verificat...

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

Transitioning into project management in the medical device industry blends technical acumen with strong organizational skills. A typical day involves...

2 weeks ago
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RE: How to communicate effectively between team mates in project team ?

A project manager’s ability to adapt goals while preventing scope creep also hinges on understanding the personal challenges team members may face. Im...

3 weeks ago
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RE: Balancing Stakeholder and Customer Values

Balancing value between stakeholders and customers often hinges on project context, timelines, and long-term strategic goals. On one hand, prioritizin...

3 weeks ago
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RE: Role of risk management in medical device projects

Regulatory risk is indeed a significant challenge in medical device project management. Even when the team has meticulously planned for FDA approvals,...

3 weeks ago
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RE: Managing Risks from External Dependencies

Project managers can cope with external risks, such as supplier delays or supply chain disruptions, by implementing proactive strategies and maintaini...

3 weeks ago
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RE: Transitioning to New Technologies During an Ongoing Project

Incorporating new technologies into a project depends significantly on the stage of the project and requires careful evaluation to balance potential b...

3 weeks ago
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RE: Design Verification Failures

When verification tests fail, the first step would be to distinguish between a test design issue and a device design issue. For example, a medical dev...

3 weeks ago
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RE: Ring Fenced

I’ve never experienced being a ring-fenced employee after a company was sold off, but it sounds like a bad situation. From what I understand, an advan...

3 months ago
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RE: The Eight Fundamentals of Legal and Consultants

Consulting and legal services are critical to the success of medical device companies, especially when navigating regulatory submissions. Regulatory c...

3 months ago
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RE: International Contract Law

International contract law plays a critical role for medical device companies seeking to expand into foreign markets. These companies must navigate a ...

3 months ago
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