There is definitely a difference between verbal agreement and written agreement. Verbal agreements don't seem very solid, and can be manipulated if t...
I agree with the fact that if there is a business deal between two people, it shouldn't involve other family members. Therefore, I don't think that t...
Dr. Simon, I learned a lot from this course, and I think I have a better outlook on what to expect in terms of going into the industry. I haven't had...
I also agree with Adrian. If there is a set up for a collaboration, the organizational structure shouldn't matter, but more so that the companies are...
I think its best to work with people who are more knowledgeable in their area, than with people you are close to. I think its a bad idea to work with...
I do not currently work in an organization, but if I had to pick the type it would be a matrix organization. I like that with this type of organizati...
First, I'd want to make sure that everyone in the project understands what the device is, its purpose, its design, and how it will be processed. Once...
one factor to consider is the assessment of the risks of the device. With this assessment you can determine the severity and number of harmful events...
Risk Management is required by the ISO 14971, and must be completed by the company. The company will go through the cycle of assessing, evaluating, m...
I think a successful validation process involves repetition and numerous trials of testing. I haven't had experience in the industry with medical dev...
Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can...
I also had to complete Requirement Documents and Test Plans for my capstone senior project. I agree that it does take a lot of time to complete becau...
I'd also like to add on the importance of risk analysis for a Design Control System. Overall, everything boils down to the well-being of the people, ...
I also agree, the DHF documents should always be updated throughout the project. I have not had experience dealing with DHF files but based on what I...