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 in...
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 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...
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...
I believe that in order to be prepared for upper management, you need middle management experience. Middle management works with both upper management...
My team had their first meeting last Saturday. During this meeting we discussed everyones role and what documentation is necessary from each departmen...
Risk-benefit factors for assessment of medical device risk includes: 1) Severity of harm 2) Likelihood of risk 3) distribution of nonconforming device...
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 man...
I read another article on risk management and it mentions other errors: 1) Lack of integration: silos between risk management and development 2) Under...
A validation is defined as conformation by examination that the particular requirements for a specific intended use can be fulfilled. Examples of when...
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 p...
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 success...
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 ...
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 quali...
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 ......