Yeah, a bandaid would be like class 1. A needle or something like that would be class 2. Class 3 would be like a pace maker. There are very clear legislation that provides tremendous amounts of guidan...

I think it depends on the current financial situation of the company. If the company is doing really well then they might be able to bite the bullet. Otherwise, they might have to re-prioritize projec...

I think the way to increase emotional intelligence really depends on the person. Every person is different. Some people learn through experience. Some people learn through visual stuff like movies. So...

Yes, I think consolation is a great option for new graduates if they do not have anything else lined up. I personally do not have consulting experience. I would consider consulting in the future if it...

I thought the course was really cool and taught you the stuff you need to know. As for improvement, not sure, I think the course was developed in a really good way. Maybe, we can have more groups to p...

No, I think this is all there for a reason. There is a reason why the laws were passed in the first place. You gain someone's favor by spending a lot of money on them. As for the awkward situation, th...

I think that this is not a bad idea in certain situations. For example, don't we have an executive branch in our government. It is important to make decisions fast and sometimes its just easier when o...

I think that when making a team. It is important to have a diverse group with a diverse way of thinking. Additionally, it is important to have a subject matter expert from all related areas like quali...

I think I can be good at both. The top level is more strategic and they think more long term. The bottom level is much more technical. However, I think that as an employee. I would be a lot more helpf...

I think risk acceptance does not increase the risk nor does it keep it the same. It decreases the risk, because you know it is there. If you know there is a chance it might rain. Do you bring an umbre...

I have seen this used in a variety of ways as well. Once can use it to characterize the risk certain materials can have in a medical device in a surgical procedure. Maybe certain materials might react...

Risk assessments are definitely necessary for medical devices. Ideally you want to design out the risk. But, if you cannot. You can reduce the risk or add a warning about it. In everything there is ri...

Yes, every little change needs to be documented. This might seem tedious, but it is very important for traceability. There are a lot of different systems used to accomplish this. Usually, you will nee...

There are numerous kinds of softwares out there. I think it would be helpful to allow all key members to have access to it, so they can update it. That way, you are able to relieve some work from the ...

I think it might be helpful to include the methods for the validation and the timeline. Think about it, if someone reads it. You will also be able to communicate timeline and the method. That way you...