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 experience in working within Clinical Trials, however, as ...

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 basic and high level approach. The simulations were...

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 engineering career. As expansion to these type of cours...

In agreement with this. You can have two similar functioning products but have different risk. An implantable suture that biodegrades into the body would have significant risk as these sutures are use...

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 medical device or drug. The same issue occurs, when a...

Outside of the budget and resource issues that others above have pointed out, it would be interesting to consider conducting a clinical study depending on where the issue you are tackling is most prev...

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 product, let alone a medical device or drug, that didn't...

This is a very good observation. Contracting employees has long been a solution for big medical device companies to control budget constraints. The way this usually works is a big project comes alon...

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 would like to add some of the minor cons that may o...

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 vagueness. At the start of production, this helps...

At my company most non-conforming issues usually stem from either operator mistakes or product not conforming to QC testing. When non-conforming issue occurs due to operator error an investigation is ...

Grandfathering a project due to changes in a quality system usually consider the following components: project scope (ex. changes to processes, documentation, drawings, validations) + area of grandfa...

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 company are falling behind for the year I have notice...

Emotional intelligence is highly important in negotiations. I believe this is one of the few things that is difficult to teach as emotional intelligence can vary greatly person to person and is almos...

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 complacent with innovation and more resistant to ...