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Forum Replies Created

RE: Distinguishing Between Hazards and Hazardous Situations in Risk Evaluation

In my opinion, it’s important to evaluate hazards and hazardous situations separately because they focus on different aspects of risk. Hazards are the potential sources of harm, like exposed electrica...

In forum Risk Analysis for Medical Devices

7 months ago
RE: Risk Management in the Manufacturing Process

Based on the lecture, risk management is not confined to a single phase but spans multiple areas, including product design, manufacturing, and post-market processes. As discussed, avoidance is often t...

In forum Risk Analysis for Medical Devices

7 months ago
RE: To risk manage or not to risk manage?

Risk management is clearly a critical part of the planning phase for medical devices. It ensures that risks are identified, analyzed, and mitigated early, preventing costly mistakes and ensuring patie...

In forum Risk Analysis for Medical Devices

7 months ago
RE: Design Matrix Content

I think these four columns give a solid starting point, but adding a few more could definitely enhance the matrix. A ‘Timeline’ or ‘Deadlines’ column, for example, could help keep track of when each d...

In forum Introduction to Design Controls

8 months ago
RE: Capstone Project Proposals (Shortened PDF)

My capstone project focused on using machine learning to detect defects in roll bearings. We trained models on a variety of datasets to identify early signs of bearing wear and tear. One challenge we ...

In forum Introduction to Design Controls

8 months ago
RE: Design "Overvalidation"?

Totally agree on how industry deadlines can limit the number of inputs! From my own experience in school projects, we had to prioritize essential features to keep on schedule. In a real industry setti...

In forum Introduction to Design Controls

8 months ago
RE: Long-term customer relationships in the face of increasing competition

It’s so true that getting the sale is just the start. The real win is keeping customers coming back, and that’s where long-term connections are key. Businesses need to make people feel valued, not jus...

In forum Marketing and Sales

8 months ago
RE: Building marketing trust in medical devices: healthcare providers vs patients

I think medical device companies can make a huge difference by being upfront and honest in their marketing, not just trying to sell a product. For doctors, it’s all about the evidence—showing real dat...

In forum Marketing and Sales

8 months ago
RE: Placebo's Impact on Pain-related Clinical Research

I find it fascinating how researchers try to keep the placebo effect from skewing the results. One of the main methods is blinding. In single-blind trials, participants don’t know if they’re getting t...

In forum Clinical Research Basics

8 months ago
RE: What is not seen in Clinical Trials?

Clinical trials are so controlled that they sometimes fail to show how a treatment works in real-world settings. Things like a person's lifestyle, environmental influences, or even how consistent they...

In forum Clinical Research Basics

8 months ago
RE: Discussion Topic: Quality Assurance vs. Quality Control

Switching between the two can be possible, but it might depend on the skills you’ve developed. Moving from QC to QA might be trickier since QA requires a deeper understanding of systems and regulation...

In forum Quality Control and Quality Assurance

9 months ago
RE: Most effective ways to manage risk in the context of Quality Assurance for high-risk medical devices (Class III)

For Class III medical devices, which come with higher risks and stricter regulations, QA has a huge role in making sure safety standards are met early on. During the design and development stages, QA ...

In forum Quality Control and Quality Assurance

9 months ago
RE: Common challenges faced while auditing a Quality Management System (QMS) in the medical device industry & how can they be dealt with

During audits of a Quality Management System (QMS), common issues that pop up include incomplete documentation, non-conformities with procedures, and missing or outdated training records. Companies of...

In forum Quality Control and Quality Assurance

9 months ago
RE: Project on time and within budget: What should be the strategies of a project manager?

In my opinion, communication is one of the biggest factors—keeping everyone on the same page helps avoid costly mistakes. Regular check-ins with your team can catch potential issues early on, saving t...

In forum Intro to Project Management

9 months ago
RE: Academia or Industry Preference?

For me, I think working in the industry side of EEG companies would be a better fit because it aligns with my research and interests. My work focuses on EEG technology, and I love the idea of taking t...

In forum Introduction to Medical Device Development

9 months ago
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