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 ma...

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 informa...

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 memo...

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 real...

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...

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 complete...

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-p...

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, proba...

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 ...

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 seali...

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 de...

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 a...

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 ...

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 discusse...

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 quali...