Since the DHF is important for both informative purposes and audit it is essential that the file maintain accurate information as a "living document". The best step towards this is having a dedicated ...

Design controls are mandated by the FDA according to 21 CFR (Code of Federal Regulations) towards medical device manufacturers. They are guidelines that help to ensure a proper quality device is creat...

Placebos have been viewed as a necessary process in bolstering scientific proof on the effectiveness of products and evidence that one product is superior to another, within many industries. Personall...

In my opinion double blind studies are more accurate as it sets a reliable baseline for the trial. As an example from the lecture would be the double blind multi-center study. In this example Dr. Simo...

Having clinical trial experience is definitely advantageous in the medical device field as you encounter problems that may not have been thought about during the design of the product, and gives good ...

There are multiple strategies that medical device companies utilize to roll out their devices. Medical device companies utilize strategies that are focused on marketing products towards medical profes...

One grand strategy that is frequently used in medical devices and technology companies is product development. Product development deals with the company investing heavily in research and development ...

Interesting video with of course an exaggerated view but definitely touches on a lot of the concepts discussed in this weeks topic. Due to the lack of technical expertise each department was not able ...

Netflix financials and state of company. P/E ratio: 244.39 Gross Margin: 31.72 Operating Margin: 4.3 ROI: 3.49 Revenue: 8.83 Billion Market Cap: 86.13 Billion Share Price: $199.49 EPS: 0.15 vs 0.16 e...

Public vs Private companies, the largest difference between the two is that private companies are not publicly traded, while public companies have shares traded on exchange funds available to the publ...

For positions out of school I believe it is more important in determining the type of experience you will receive from the company and the depth of your role, rather than the type of company. Initiall...

My current role dealing with engineering change controls involved document control and properly maintaining records of changes in manufacturing of medical device and pharmaceutical products. This info...

The dynamic is interesting and I have a middle ground perspective between the two fields. As a Process Engineer in my companies manufacturing and science technology group my role deals in bridging the...

Quality can definitely burdensome for medical and pharmaceutical companies and is a key driving factor in the high cost of delivering good products to the consumers. For a portion of my role as a Proc...

The user fees increase could be a benefit for the industry as it has the potential to increase the regulatory timeline for FDA. This can allow for drugs and medical devices to reach market quicker and...