One thing I really enjoyed about the course is that we got to explore so many of the other positions available in industry. I have only been in the industry for a year or so and did not realize how…   Read more»

A patent is a piece of paper that allows one to have ownership of an idea or invention. NDA is known as a non-disclosure agreement. It’s an agreement in which people or companies agree to keep information confidential. So basically…   Read more»

In any situation I believe that a written contract is necessary. The difficulty in proving an oral contract is that you must rely on the memory of the parties and other evidence. Depending on the memories of people allows one…   Read more»

If I am to form a project team, I would choose people who have the qualification and experience over people who I know get along with each other. From my work experience so far, people who do not really get…   Read more»

I believe that in order to be prepared for upper management, you need middle management experience. Middle management works with both upper management and lower levels of the company. As you mentioned, middle management works to fulfill the vision of…   Read more»

My team had their first meeting last Saturday. During this meeting we discussed everyones role and what documentation is necessary from each department. We discussed which documents should be completed as soon as possible because it is needed from other…   Read more»

Risk-benefit factors for assessment of medical device risk includes:
1) Severity of harm
2) Likelihood of risk
3) distribution of nonconforming devices
4) duration of exposure to population
5) False-positive or false-negative results
6) tolerance of risk
7) risk factors for healthcare professionals and caregivers

A few points for risk management: 1) ISO 14971, this standard is accepted throughout the world 2)FMEA is not risk management 3) establish a risk management policy and procedure 4)keep severity, probability, and risk levels simple 45use risk management as…   Read more»

I read another article on risk management and it mentions other errors: 1) Lack of integration: silos between risk management and development 2) Understand and incorporate “intended use” in your risk management process 3) Failing to conduct and document risk-related…   Read more»

A validation is defined as conformation by examination that the particular requirements for a specific intended use can be fulfilled. Examples of when validations is required are sterile package sealing processes. An example of when a validation is not required…   Read more»

There are a lot of things that can go wrong when you have insufficient design controls. The obvious outcome would be a decrease in quality which can put your costumers in danger. Sometimes when the design control is too detailed,…   Read more»

I recently finished an internship with a medical device company and two of my projects involved drafting a validation. I have a few advices to successfully complete a validation. 1. Try to draft it asap and e-mail all the people…   Read more»

One of the task I had to work on as an intern was validation. The first step for a successful validation is that everyone on the team does their part in a timely manner. For example, the team ensures the…   Read more»

Minutes for meetings has been very important and useful to me in the medical device industry. For example, I had to take minutes for a quarterly quality meeting that we had. In the meeting we discussed some important points that…   Read more»

I had to draft up the validation and protocol for two machines a few months ago. The plan used is known as Acceptable Quality Limit (AQL). It is a …”statistical method that is used to test the quality level that…   Read more»

If I was involved in clinical research, I would want to be a clinical research coordinator. A clinical research coordinator’s job is to make sure everyone in the team is complying with all the rules and regulations. They also work…   Read more»

I believe placebo-controlled trials are very necessary. There is something known as the placebo effect which is when a placebo drug or treatment is not due to the actual drug/treatment but due to the patient’s belief. If patients knows what…   Read more»

If the job is more desk work related such as a statistician, bioinformatics, ect, a clinical background is not required. I believe a clinical background is necessary if you are are going to directly deal with patients.A principle investigator and…   Read more»

The color of brands is extremely important in marketing and brand design. It is stated that, “…90% of snap judgements are made based solely on color.” In healthcare, the leading color used by brands is blue. Blue is associated with…   Read more»

Marketing is when you get costumers and potential buyers interested in your company’s service or product.E Jerome McCarthy came up with 4 P’s of marketing: 1. Product: Some questions asked are who is the target for this product? Is the…   Read more»