I agree that internal and external factors can really shorten or extend a product’s life cycle, especially in tech-driven fields like medical devices....

@ms2768 I think your perspective is really interesting, especially since you’ve experienced both fully in-person work during the pandemic and now a h...

I would prefer to work under a project manager who communicates mainly in person because face-to-face interaction makes expectations clearer and helps...

I prefer working in a small team because it’s easier to communicate, stay organized, and make decisions without things getting slowed down. Everyone’s...

In past projects, I’ve used brainstorming and the Failure Mode and Effects Analysis (FMEA) method the most. Brainstorming is great for quickly generat...

At my previous internship, I learned how easily hazards can turn into serious situations if not managed properly. For example, imagine working at a co...

I definitely believe risk management is an essential part of the planning phase. It’s not a waste of time or money; it’s actually a smart investment t...

I think the four columns in the Design Matrix, inputs, specifications, validation, and verification, provide a strong foundation, but they might not b...

I think our current design control systems have definitely come a long way since the Therac-25 incident, but I’m not sure they’re strong enough to com...

I agree that product development is an evolutionary process that requires careful control and documentation to maintain quality. From my perspective, ...

Design control plays a huge role in developing safe and effective medical devices, but problems can definitely arise when it isn’t followed properly. ...

I agree that catching issues before verification officially starts is the best case, because once the verification protocol and reports are underway, ...

I was thinking about this too! From what Dr. Simon explained, design verification is all about making sure our design outputs match the design inputs,...

I really like your choice of wanting to be a Clinical Investigator. Investigators have a key responsibility in clinical research; they not only enroll...

I see what you mean; it might seem like a single-blind study should be enough. However, according to this week's notes, bias can occur not only from t...