Based on the EU government, guidance documentation is not necessarily obligated to be followed by law. They are to provide clarity on directives based...
I work for a cardiovascular company that deals with an FDA classified class II medical device that is sold internationally, specifically Europe. A ca...
Based on this weeks lecture the EU regulatory focuses on risk and essential requirements checklist. The FDA analyzes more so on efficacy and the FDA m...
One of the major marketing strategies used within the company I work at is the fifth P. Our products are mostly used by surgeons and physicians; there...
Personally, I have not experienced working out a legal contract at work first hand. However, I was informed that our company had a major fall through ...
Two years ago, I was working in a human performance lab that was gathering data on neuromuscular activity from patients after chemo treatments. The fo...
I never directly dealt with a non-compete agreement but my brother in law has. He signed the agreement two years ago and found out recently the conseq...
Verbal agreements much be accepted by the law, but I was always taught that “if you don’t have it in writing then it doesn’t mean anything.” This sayi...
This course was very beneficial in learning about the different design controls, business and regulatory aspects of the medical device industry. I pre...
Based on my experience, a functional organization seems to work well in large companies. Yes, a disadvantage is the creation of silos but that can alw...
I work as a product engineer at a company which has a matrix organization and the one constant is disagreements between departments. Whenever we have ...
As an undergraduate I had to form a project team for a senior design project and I formed a group with two other friends. I worked with these two frie...
At Getinge, the sample size is determined mostly from the risk index. Since Getinge’s main acute therapy product is Intra-aortic balloons the risk ind...
As a co-op at Getinge I was able to work on a project associated with updating the PFMEA (process failure mode effects analysis). This one document la...
The ISO 14971:2012 risk management requirement is not clear because one cannot define” as far as possible.” The risk management team can find ways to ...