I agree with a lot of the post above in regards to the amount of paperwork that potentially needs to be done within this field. I don't have experien...
The simulations were very helpful because it teaches you different ways to think outside the box in terms of resolving different issues from a very ba...
MDD and AMDD are very good classes to get your feet wet in understanding the different aspects of medical devices and what can lie ahead in your engin...
In agreement with this. You can have two similar functioning products but have different risk. An implantable suture that biodegrades into the body wo...
I agree with this point. Failed clinical trials is bad press for a company. Articles usually pop up when a company's clinical trials fail for a medi...
Outside of the budget and resource issues that others above have pointed out, it would be interesting to consider conducting a clinical study dependin...
I don't necessarily agree that having zero GMP will lead to lower cost in anything. I'm not sure what type of buyer would want to purchase any produc...
This is a very good observation. Contracting employees has long been a solution for big medical device companies to control budget constraints. The ...
I agree with this. CAPAs are meant to self correcting actions that a quality system intakes to ensure products and processes are in conformance. I w...
In agreement with this. The ambiguity for GMPs established within a start-up opens itself for improvement and new policies that will, in turn, reduce...
At my company most non-conforming issues usually stem from either operator mistakes or product not conforming to QC testing. When non-conforming issu...
Grandfathering a project due to changes in a quality system usually consider the following components: project scope (ex. changes to processes, docum...
From my experience if sales numbers are lagging, there needs to be a way to compensate that by finding ways to SAVE money. Usually if sales at my com...
Emotional intelligence is highly important in negotiations. I believe this is one of the few things that is difficult to teach as emotional intellige...
I believe I can relate to this. I have noticed that engineers in a leadership role for an extended period of time within a company, can at times, get...