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 a certain way…   Read more»

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 risk, but you need to…   Read more»

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 need to have a number of people…   Read more»

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…   Read more»

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 are able to…   Read more»

I think for the most part yes, it is common for a device to go through all of these steps. However, I think, you might have to go through more steps and more documentation. I feel like the projects we…   Read more»

I think that corporations are taking effort to maintain corporate responsibility but they are all doing it in very sneaky ways. For example, say if a company wants to show they have neutral emissions. They might do so by buying…   Read more»

Meeting minutes are very important, because it’s hard to remember every single little detail. And, you don’t wan to have another meeting to figure out what was missed. It is also a better habit to develop documenting and taking good…   Read more»

Yeah, I think as long as you are trained in all the ethics you have to be trained to in your respective field and you do not break anything in your experiment.I think you are good to go. Just on…   Read more»

I don’t think the placebo effect can have a negative effect on a trial as long as it is documented, additionally if the study is double blind. I think we are good. I think there are a lot of studies…   Read more»

There really aren’t that many other ways. What would you say? You will get a free iPhone? You will get a Starbucks gift card? Those gifts kind of makes the whole thing demeaning. Or, would you be like help humanity?…   Read more»

I think it might be a phase for me, to be honest. I know a lot of people say it is more lucrative, however without sales experience. It might be hard to crack into the role. I think it would…   Read more»

You need to see the legality behind gifts, food, etc. I am not sure if you are allowed to give all that to people you are trying to do business with. But yeah, trust is very important, but your job…   Read more»

It depends on your interests and passions. Also, the salaries sales might be lower, but you can get a lot of commission. I would recommend maybe doing an internship in this field to see if you like it. Also, I…   Read more»

I think as an engineering student, you are already familiar with business principles. I think a class in Project Management might be helpful though. I think, in the end, you are ready to learn and tackle business problems because of…   Read more»

Being an intern is very different than being a co-op which is very different than being a salaried employee. Once you are salaried, you have a lot of respect. You are a permanent employee, you get benefits. You will see…   Read more»

To be honest, I would prefer to work for a larger company than a smaller company. You need to think about stability. How many startups go under? How many job scams are there? There is just too much risk, you…   Read more»

I agree that a lot of places uses technology, but there are a lot of places that still rely on paper based systems. As a result, I think we need to have a roll over period to get everyone to…   Read more»

I think we do our best, when we are diverse. That is just my honest opinion. I think something unique happens when you take the best from a large section of demographics. You have a big variety in thoughts and…   Read more»

I honestly do not know. I would recommend speaking to your legal or regulatory affairs team. Their expertise might be able to provide you with better guidance.