Based on the EU government, guidance documentation is not necessarily obligated to be followed by law. They are to provide clarity on directives based on standards. The council approves the directives...

I work for a cardiovascular company that deals with an FDA classified class II medical device that is sold internationally, specifically Europe. A cardiovascular medical device that I love learning a...

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 makes the sole decision on if the medical device me...

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; therefore, the marketing group will hold meetings with ...

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 with a legal contract with a warehouse that distri...

Two years ago, I was working in a human performance lab that was gathering data on neuromuscular activity from patients after chemo treatments. The focus of the research was to see how chemotherapy fr...

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 consequences of it. When he decided to defer his contrac...

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 saying comes into use whenever I work on a project. Wh...

This course was very beneficial in learning about the different design controls, business and regulatory aspects of the medical device industry. I previously took your project management course and pr...

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 always be resolved. Having an IT, marketing, finance...

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 a major project we have meetings with the lead of ...

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 friends previously on other projects and we worked ext...

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 index significantly changes the sample size while run...

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 lays out each process for creating the final medical...

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 mitigate, eliminate, prepare for risks which can h...