Forum

mme54
@mme54
Trusted Member
Joined: Sep 10, 2023
Last seen: Mar 31, 2025
Topics: 1 / Replies: 88
Reply
RE: Change in Scope Due to Customer Requests

When customers request changes to the project scope after execution has started, it is essential to follow a structured process to prevent scope creep...

2 weeks ago
Reply
RE: Planning Techniques

Planning is undoubtedly a crucial phase in project management, as it lays the foundation for successful execution. I appreciate the emphasis on struct...

3 weeks ago
Reply
RE: Enhancing Quality Assurance: Lessons from the DePuy ASR Hip Recall

Patient-reported outcome measures (PROMs) can significantly enhance QA by providing real-world insights into device performance and usability. Digital...

3 weeks ago
Reply
RE: Company collaboration

Collaborations like the one between BoneFix and FactoSet offer strategic advantages when companies lack the in-house expertise, technology, or resourc...

3 weeks ago
Reply
RE: Company collaboration

Collaborations like the one between BoneFix and FactoSet can provide significant advantages when companies lack specific expertise or resources. By le...

3 weeks ago
Reply
RE: Significance of Scope Verification in Project Execution

Ensuring effective scope verification in medical device development is crucial to maintaining compliance and preventing costly rework. One major chall...

3 weeks ago
Reply
RE: Role of initiation process in medical device project

The initiation phase of a medical device project is foundational, as it defines the project's direction and feasibility. Several key inputs—such as th...

4 weeks ago
Reply
RE: Difficulty of Changes

The ranking of change difficulty in medical device development makes sense, as changes to SOPs are generally easier to implement compared to modificat...

4 weeks ago
Reply
RE: Email Communication

Managing emails effectively is crucial for maintaining productivity as a project manager. Setting up automatic sorting rules and filters is an excelle...

4 weeks ago
Reply
RE: Importance of Adaptive Project Planning

Adaptive project planning is crucial in research-driven medical device development, particularly when working with evolving technologies like injectab...

4 weeks ago
Reply
RE: The PDCA Cycle – An Important Framework for Medical Device Projects

iThe Plan-Do-Check-Act (PDCA) cycle is undeniably a cornerstone of continuous improvement in medical device development, helping organizations maintai...

2 months ago
Reply
RE: Risk Mitigation and Continuous Improvement

Risk mitigation and continuous improvement are critical components of effective project management, particularly in medical device development, where ...

2 months ago
Reply
RE: Addressing Verification Failures

Label adhesion failure during water submersion testing presents a multifaceted challenge that requires a structured root cause analysis before conside...

2 months ago
Reply
RE: The PDCA Cycle – An Important Framework for Medical Device Projects

The PDCA cycle is a fundamental tool for driving continuous improvement in medical device projects, but its success depends on how well an organizatio...

2 months ago
Reply
RE: Design and Development Plan

A well-structured Design and Development Plan (DDP) serves as the foundation for successful medical device development, ensuring regulatory compliance...

2 months ago
Page 2 / 6