Honestly, this was a really informative course. I have almost 3 years of experience in the med device industry now and there was a lot that I didn't k...
I've had to sign a non-compete agreement for my past 2 jobs. So anytime I interviewed for a position, I had to let the company I was interviewing for ...
I've had a couple experiences with an NDA. During my undergraduate career, I worked at a start-up that required me to sign an NDA so that I am not leg...
If all people were available meaning, that they have the capacity to work on my project, I would prefer to pick people knowledgeable in their departme...
The organizations that create these regulations are offering a product. As such, they aren't going to just give that product away for free. The organi...
As most medical devices go through phase-gated activities, a design review meeting is very important. It basically landmarks when the next phase can b...
Verification is one of the most critical parts of the design process. It is the stage proving (or verifying) that all the work that has been conducted...
My experience has always been with design validation so I will only discuss that side. To have a successful design validation, the previous legwork ne...
These two documents are definitely necessary and are independent of one another. The DID is needed to create the DSD. Each design input should have a ...
I want to update your claim on the EU classification requirements. Your reference article is on MDD, Medical Device Direction but it was replaced by t...
As you have said, meeting minutes are very useful for the DHF files since they capture the activities and decisions made. I have worked with many lega...
I would prefer to be a sponsor for a clinical trial. They are the one's who actually develop the trial and create the case for why it's necessary. My ...
There are ethical issues when applying a placebo in a clinical trial. It becomes a case of what's better for the greater good. Would you rather save a...
I feel that are a lot of ethical issues if a patient wishes to undergo an unapproved clinical trial. Firstly, there may be a big reason behind why the...
One aspect of color comes into the branding. Companies want to have a color palette that distinguishes itself. If you see red and yellow together, you...