I've had to sign a non-compete agreement 3 times so far. First was when I worked for a consulting firm - I was not allowed to work directly for their ...

Fortunately, I have not yet been laid off and gone through this. However, I have gotten a release letter from when I wanted to leave my consulting fir...

Consultants are generally hired when a company does not have the specific resources for a task/project or the company does not have enough resources t...

Every company I've worked for has so far been a matrix organization. While I have not had experience functional or project-based organizations, I feel...

I concur and would like to add that it may be acceptable to say upper management answers the question "What do we do?" and the middle management answe...

I think it really depends on what you're trying to accomplish. I've used all three that you have mentioned; FMEA, Brainstorming, and Fish Bone Diagram...

ISO 14971 is the ISO regulation governing Risk Management and its major requirements for medical devices are: Identify risks Estimate the potenti...

I've participated in a couple of audits. US FDA, Korean FDA, Internal, and MDSAP. My participation was always limited to specifically my documents so ...

I've done and am actually in the middle of a shelf life validation for raw materials and final device. We've included in it packaging, transportation,...

They are related in a sense that both are used medically but they both have different levels of risk. Medical devices, whether it be implants or blood...

From what I have observed during my working experience in Medical Device companies as Production Engineer, Quality seems to operate under two main str...

@bjv9 Yeah, absolutely, some countries have have regulations that are more strict than the US and for that reason some drugs or devices banned in ot...

My previous employer sells blood typing kits to many countries around the world and we are regulated by several bodies around the world. While most of...