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 monitoring and taking action on trends from complaints or general inquiries from…   Read more»

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. The process FMEA and design FMEAs are…   Read more»

@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 PMS review and they are conducted for the product or…   Read more»

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 personnel tend to face when interacting with their R&D…   Read more»

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, cosmetics, and products that emit radiation” (“What We Do,” 2023)….   Read more»

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 the most compliant and efficient systems in the…   Read more»

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 “go public” for most companies. There are…   Read more»

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 ensuring the customer is informed and that any marketing…   Read more»

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 telephone, fax, or in-person. Now companies have social media, websites,…   Read more»

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 capacity post-market. In industry, once a product is sold commercially, there…   Read more»

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 fact that there has likely been previous research conducted…   Read more»

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 career and ultimately what their career aspirations…   Read more»