There is definitely a difference between verbal agreement and written agreement. Verbal agreements don't seem very solid, and can be manipulated if there isn't proof of the agreement. Written agreem...

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 the restrictions are too much. Because its a dinne...

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 any experience in the industry yet, and before ta...

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 working together and being efficient. However, c...

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 people you are close to just in case something go...

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 organization you can transfer knowledge about the project wi...

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 we understand the device and what is going to hap...

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 associated with this device. Also, the probabili...

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, managing, and then measuring the risks. The compan...

I think a successful validation process involves repetition and numerous trials of testing. I haven't had experience in the industry with medical devices, but I have done research where we were requi...

Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can also aid in risk analysis. By verifying every as...

Verification is an important part in developing medical devices or products, and can really help in making sure the products set out to do what they are supposed to. For instance, take tylenol for ex...

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 because of the major details that are involved. Howeve...

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, and that is why the FDA needs to ensure that the p...

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 have learned so far, I think that updating these ...