A possible method to improve communication between QA and QC is to have them in the same department, which is done relatively often in smaller companies. Even if there are still two separate divisions...

I believe quality assurance is a much more difficult task compared to quality control. Spotting a defect takes a lot less effort than reverse engineering the process and determining what caused that d...

@jfm23 I agree that QC/QA should be an independent body, specifically to ensure a QC/QA professional is always in the building. However, as @31623940 touched on, the responsibilities of QC/QA should n...

@raina I was under a very different impression about Regulatory Affairs! Before this week's lecture, I thought that Regulatory Affairs was basically synonymous with Quality Assurance in a company. Aft...

I don't necessarily think the 501(k) process discourages innovation, but it does definitely make the approval process easier if a medical device is close enough to an existing product. Saving some tim...

@ma3295 I would agree that reapproval is needed in many cases of updating the AI in a medical device, but not all cases. I view the AI as a part of the device that contributes to the success of the fi...

@pz98 I would say that in industry, long term goals are just as important as short term goals. While they provide results faster when compared to when the goal is formed, they often cannot allow the c...

@ahmed-elmonier I would definitely say the level of evidence needed before moving on should depend on the details of the condition. For example, if a new technology is being developed to potentially r...

@ahmed-elmonier I wouldn't use an outside lab for industry for the reason you mentioned, the reduced control and monitoring over the lab. For projects to maintain consistent deadlines, adding a non-af...

I would agree that people not doing their share of the work is a major problem in teamwork in general, but I would argue that in the workplace, disagreement over ideas would be a larger problem. In th...

During my internship at a medical device company, I made use of Microsoft Excel and PowerPoint to document my progress. Excel has multiple built-in templates to help with work breakdown structure, inc...

@andrewg I would agree that working on the initiating phase for an extended period of time stagnates the project and can lead to deadline issues later on. However, I wouldn't say that less emphasis sh...

If I could redesign any medical device, I would attempt to change the current design of an artificial larynx. The original device is incredibly useful for its ability to allow those with damaged vocal...

While I agree that it is definitely unreasonable for students to balance full time work and a full courseload, I would say that it is worth doing if the opportunity is presented to you. Last semester ...

I agree that both industry and academia both have great impact and promise, but I'd like to add that how fulfilling each is highly dependent on your unique needs, personality and abilities as a person...