In a clinical trial, I would perform the monitoring duties. I would choose this because I would be able to travel to all of the locations where the clinical trial is taking place and ensure the integr...

While I have never participated in a clinical trial as an investigator or patient, one idea for being able to track AEs is by having the patient have a wearable device such as an Apple Watch to help m...

As mentioned above, responsibility (or blame) may depend on the wording used in the informed consent form and in the ethical practices of the sponsors and investigators running the clinical trial. For...

A vision statement is a general and broad statement about what a company wants to accomplish. One example is from Boston Scientific. Their vision statement is, "Boston Scientific is dedicated to trans...

One of the advertising campaigns that has stood out has been the Nike poster featuring ex-NFL quarterback Colin Kaepernick. The ad is a close of photo of his face with the words, "Believe in something...

One of the most common ways that the fifth "P" of marketing is used in today's environment is by using brand ambassadors on social media. While almost all companies have social media accounts of their...

Choosing a job based on corporate structure is an interesting point to bring up. While I have never formed an opinion of a company solely on whether it was an LLC or a Corporation, I think it is impor...

As stated in many of the posts above, the avenue of setting up a business depends on the number of people involved and the type of business being set up. However, one thing that was not mentioned is t...

One example for filing for a DBA is for a business which has been bought by a new owner, but continues to operate as the same name. I once worked for a company which operated under a DBA. The situatio...

One important skill for a QC Engineer to have is investigative skills. The role of QC is not only identifying non-conforming products. Failures sometimes require a root cause analysis. A root cause an...

In my experience, inter-department relationships are best maintained by good communication. The quality signature on a Change Notice can often be the hardest to get, so a strategy that I use is to inf...

Using emerging technologies to assist in quality can be a very helpful tool for QA/QC departments. For examples, using AI to perform inspections along the production line can help ensure consistent in...

One of the major recalls in the last few years has been the J&J/DePuy Hip Stem Recall in 2010. The hip replacement was a metal on metal implant which had a high failure rate and was leaving patien...

Working in the medical device industry, it may seem like the FDA rules and regulations are too strict and unnecessary. Compliance and design controls are major things that some companies spend years t...

For the physician to realize his or her goal of creating a medical device, he or she would need to surround himself with others who are knowledgeable and experienced in product development, process de...