So I remember my interview for a company I worked for previously hired me as a result of my stance on confidentiality and being able to hold trade secrets. The interview was very laid back but with about five managers…   Read more»

DuPont Tate & Lyle LLC is a joint venture company.  Tate & Lyle is a world-leading renewable food and industrial ingredients company and Dupont is a global science innovator. Individually I believe that both have a functional organizational framework. However,…   Read more»

As we have become a global society and business is no longer local but international with the touch of a button transactions can take place the matrix-based organization seems to be the best fit model. With the pandemic exposing and…   Read more»

What are some benefits of implementing a risk management assessment for a device? Give the pros and what can be seen as potential cons if there are any? A risk assessment is a process to identify potential hazards and analyze what…   Read more»

If you fail to plan then your plans will fail. Planning is the greatest investment of time, talent, and thought.  I believe Risk Management is a vital part of the planning phase in any product design or development, especially in…   Read more»

The major ISO regulation governing Risk Management is the ISO 14971 adopted in 2007. Risk management is a design input and is a part of the product design lifecycle. Evaluation of risk for a medical device includes apparent risks and…   Read more»

As I  am going through this course and gaining more knowledge on medical devices and the process which it takes for them to reach the market I realize it goes back to the basics. As a scientist, the scientific method…   Read more»

There are nine components that make up design controls that build from one to the other. Knowing the goal of medical device development and meeting that goal is the outcome of the design controls. I believe the planning aspect is…   Read more»

According to the lecture, there is a difference between verification and validation in most cases. However, sometimes the verification is interchangeable with validation. If the product that you are producing is verified and the input equals the output all specs…   Read more»

As a lab technician, it is one of those on-the-job training sessions you must put into practice daily. Good clinical practices (GCP) are the guidelines that are in place to ensure safety. The FDA sets the guidelines for any industry…   Read more»

Big Pharma has established its position and those names and reputations stand highly recognized. However, the CRO is a contract research organization that is a life sciences company that provides support to the pharmaceutical, biotechnology, and medical device industries in…   Read more»

FDA regulations require a clinical trial before a product is set to market. Clinical Trials are very essential both on medical devices and on drugs. After pre-clinical data is approved it is imperative that it be tested in a controlled…   Read more»

A key to success is the ability to manage yourself well. Personal management is perhaps one of the most underdeveloped tools of an individual yet highly sought after professionally and publicly. Yesterday I saw some clips of Ketanji Brown Jackson’s…   Read more»

According to Merriam Webster, a mission statement states the purpose or goal of a business or organization. The company’s mission statement emphasizes its ongoing commitment to meeting the needs of the community. The purpose of the mission statement is to tell…   Read more»

The 5P’s of marketing with the fifth P being participation/people are changing the way marketing is presented on digital platforms. Engaging patients, consumers, participants in a non-face-to-face sale involves ingenuity and being able to be personable and convey your message…   Read more»

The streamlining of processes is cost-effective in most cases as far as consistency and conformity across the board.  “On October 5, 2021, FDA issued a final rule on the De Novo Classification Process.3 This final rule will add new regulations…   Read more»

Paradoxical as this idea and question seem to be if you take a moment to think about medical devices already on the market it is obvious medical doctors are innovators and developers of important medical devices. I am reminded of…   Read more»

Cost of Quality is the upfront cost for a guarantee in good faith practice for a product. The integrity of your brand is the reputation you have with your loyal customers. As a former quality lab technician for a food…   Read more»

@alexia-coffer you stated,  The three aspects of sustainability identified as “Triple Bottom Line,” or alternatively “Triple P: people, planet, and profit” show the balance or harmony between economic, social, and environmental aspects. These three pillars, however, are not stable but…   Read more»