In this weeks lecture, we learned about 4 different forms of risk management: Avoidance Mitigation Acceptance Transference Where do you think user training falls in the above list, and how strong of...

I agree that risk avoidance is the most ideal path to manage risk, followed by mitigation. If you make a device so it can't cause harm, then your are eve protected from improper use.     I...

  There are definitely some pro's and con's to having the project team also make up the risk management team. For instance, the members of the project team have the most intimate knowledge of the...

  I think a good criteria that can be used to determine if an upgrade should be developed and released would include some metric that compares aspects of potential device improvement to potential...

Labelling should absolutely be taken seriously for medical devices. As much as they inform what is inside the packaging, they can also indicate notable hazards, who should/shouldn't use the product, a...

  I think the translation starts with what your team is capable of measuring, and thinking of ways to use those capabilities to find a metric that relates to something meaningful in the user need...

Since DID documents often come from nontechnical personnel, they can sometimes come off as an unrealistic wish list that needs to be reeled in by technical staff in the DSD. On the other hand, the DID...

  In my experience, verification entails checking if a design meets the design specifications and requirements. For example: Does the design weigh less than 5 kg. On the other hand, validation an...

As mentioned in prior comments, meeting minutes direct functional importance can be minimized by meeting summaries, gannt charts/schedules, and other deliverables that can render many aspects of the m...

As mentioned in prior comments, meeting minutes direct functional importance can be minimized by meeting summaries, gannt charts/schedules, and other deliverables that can render many aspects of the m...

Placebo effects certainly can have an impact on clinical data, and is why clinical studies should be intentionally designed to minimize its impact where possible. As discussed in class, this can often...

I think that there is a line of how a patient should be compensated for a clinical trial. From one perspective, patients are exposing themselves to increased risk, potentially incurring additional med...

I do not think AI should be used as a replacement for Clinical Trials, nor any virtual medium. While AI and technology is growing in capability, anything it could produce would just be a model that do...

I would argue that effective sales persuasion crosses the line into manipulation once the strategy stops considering they best interests of the customer. Of course the salesperson always has the goal ...

I think that physicians should be able to be compensated for their influence on sales, but I also believe that their should be transparency. If a physician is giving an endorsement or advocating for a...