This course was awesome! It really made me think, and I actually learned so much about medical devices. The different classes, the side effects, the i...

I think both play a large role in having proof and validation. Written is important because it guarantees that every one of the particulars of your un...

For me, I think that a matrix-based works better with my personality. Matrix management is an organizational structure in which some individuals repor...

A Risk Management File (RMF) is where you keep risk management activities, documentation, and records. A Risk Management File contains proof of Risk M...

I would say anything with pointy or sharp ends, electricity, or ventilators, etc. All of these play a major role in the development of health. But it ...

I think as far as possible is as safe and as efficient as possible without creating any hardship. Many have looked to the ISO 14971 norm as a method f...

Some device changes that must be controlled are recalls, errors in paperwork(any changes made). This is important because tracking all changes whether...

Design Validation decides whether you are building the right product. Validation is the method involved with checking whether the determination catche...

The motivation behind the design control is to ensure that an arrangement has been made to be carried out by the organization and producer that guaran...

I think these only benefits patients who don't have long to live. Testing is very important and should not be used if it has not fully been approved a...

Based on research there are 3 main things that should be considered for human test subjects. The 3 main things include respect for persons, justice, a...

The best thing to do will just continue to participate in clinical trials. It is hard to determine what will work and what will not. Like you stated A...

So I commented on this a few months ago, and I still feel the same way! Researchers need a market because research is crucial for discover which medic...

Honestly, I think this is where character comes into play. Yes, a job can pay well, have incentives, and bonuses but are you actually happy at that jo...

I would love to do a partnership! I think it allows you to see things from a different perspective and gain more knowledge along the way. Comparing id...