Verification = Inputs = Outputs Verification is completed after DAD and RA, this document shows the tests that were created for each specification or requirement in the DSD to verify that the design i...

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 history of the initial design history, SOP's, and de...

Essentially MEDDEV, NB-MED, and Competent Authority Guidance Documents all have their uses and advantages. However, considering the process of NB-MED bring written by notified bodies and MEDDEV writte...

As mentioned be other fellow commentators, combinational medical device are much difficult to classify for those in the Notified Bodies, this is because according to the directives, the device would f...

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 detection of retinal pathologies. The device was ...

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 the legal department either in-house or with anot...

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 customers and shows that the medical device company is ...

Currently I am working in a medical device company that focuses on vision electrophysiology. The overall purpose of these vision testing systems is to aid optometrist and ophthalmologist diagnose thei...

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 notarized, verbal agreements cannot be used for legal re...

Policies like those restricting to provide certain payed services to physicians for example is important to understand why they are established and practiced. These policies i believe are set to preve...

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&D, learning about the regulatory and quality ...

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 ideas. The problem here is that there are moments wher...

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 an engineering team. We work closely with R&D,...

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, however it it is a common problem then it should b...

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 are some issues that a product can experience afte...