@mbonds That's exciting! Good luck with the job! Post-market surveillance is definitely an important factor to protect the company. There are some regulatory agencies that now require what's called a ...

Risk Management Files are usually categorized and displayed in a way that provides information for process risks, design risks, and use risks. So you may see them listed as pFMEA, dFMEA, and uFMEA. Th...

Minimizing residual risk relies heavily on post-market surveillance and updates to risk management files and marketing materials (claims and copy). It is critical for companies to strongly consider mo...

Technology has allowed companies to expand their ability to interact with potential customer. Companies are no longer limited to just reaching out to potential customers via the traditional ways of te...

This is actually pretty interesting as I have seen "marketing and sales" collectively as a single group or department in the medical device industry. In my experience marketing is responsible for ensu...

As the definitions of public and private companies have been stated previously, I will elaborate on the pros and cons of each. Firstly, from a financial standpoint it is typically more expensive to "g...

Document control should definitely be considered one of the foundational elements of the company’s quality management system. So, there should be great time and effort put into ensuring it is one of t...

The purpose of the FDA is to “protect the public health by assuring safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmet...

This is an interesting topic that is very prevalent in medical device and pharmaceutical companies. I too have experience in the medical device industry and have witnessed the challenges that quality ...

Someone choosing between academia and industry would have to determine what is more important to them when deciding where to invest their time. They would need to identify where they are in their care...

Research conducted for both long-term and short-term application are both beneficial and necessary. If we look at it from the standpoint that research deemed “short-term” requires less time due to the...

Deadlines are one of the top factors that differentiate industry from academia. Cutting corners in research whether in academia or industry will likely resurface, often times negatively, in some capac...