Verification = Inputs = Outputs Verification is completed after DAD and RA, this document shows the tests that were created for each specification or ...
From my experience in working in the industry, the DHF i believe should be a living document along with the DMR. I can understand that the DHF is a hi...
Essentially MEDDEV, NB-MED, and Competent Authority Guidance Documents all have their uses and advantages. However, considering the process of NB-MED ...
As mentioned be other fellow commentators, combinational medical device are much difficult to classify for those in the Notified Bodies, this is becau...
From my experience, the company that i work for proceeded with releasing their medical device which is a vision testing device for diagnosis and early...
Currently i do not have any experience when it comes to the legal area. I agree with Dr. Simon's recommendation on organizing a plan when meeting with...
Participation as mentioned by srg36, it is important for a company's marketing strategy in the sense that it creates a welcoming feeling for new custo...
Currently I am working in a medical device company that focuses on vision electrophysiology. The overall purpose of these vision testing systems is to...
Verbal agreements are usually not used or in this case highly not recommended, this is because in the legal world, if it isn't written down and notari...
Policies like those restricting to provide certain payed services to physicians for example is important to understand why they are established and pr...
Overall the course was very informative and provided insight on the jobs available in the medical device industry. My current interest is to work in R...
Working with certain people that you have a good relationship is always a good thing to have when it comes to getting work done and brainstorming idea...
Currently, I work in a functional organization structure. I am part of the Engineering department when I report to VP of engineering and I am part of ...
I believe the following is what should be followed: 1) Low Severity Hazards: Should be mitigated but it can also be considered trivial or negligible,...
I agree that Risk Management should be considered a living document to help a company document and keep track of their product post production. There ...