Consultants in my company or my previous company have been useful in bringing expertise where our group lacks or needs a third party view. For instance, my company had a large acquisition that needed ...

Honestly, this is one of the best courses offered at NJIT for younger professionals who aren't sure of what career paths may have in store for them. This definitely provides the foundation of design c...

It is important to understand the full implications of an NDA before signing. Some may sign them for their job multiple times on different patients and such. Others, like myself, will have an NDA that...

Do you ever get lost in the matrix due to having too many responsibilities with multiple project teams that it can be confusing on who you work with at the end of the day? I know large organizations c...

In terms of enlightening the manager to the importance in QC and regulatory roles, there would need to be a reason why a project is being impacted significantly due to a loss in those pipelines. There...

Organizational structures, in addition to more effective communication and autonomy in a project, provide the handoff of the project from development to post launch as well as lead the culture of the ...

In the world of medical devices, there is no such thing as a waste of money for risk assessment. When a device deals with aiding in human function with direct contact to user, then there is a need for...

Another internal risk can be seen where the transfer from prototype to process equivalent part may not be as easy due to a poor CQA list or difficulty of manufacturing of the parts. This can set a pro...

Another form of risk control during design is knowing the intended misuse scenarios and how they can be mitigated during design. Lets say they know a scalpel can cut easily and is sharp on all sides. ...

The company I currently work for does not let any sort of failures go through. Since I work at a medical device company, the product affects patient care and health which in turn, if product fails, ca...

Statistical sampling can be pretty dependent on what you are working towards. There are guidelines to follow an ANOVA for a process to validate their systems which can be very different from medical d...

As said by mcf29, there are many different qualifications that the manufacturer goes through to validate their processes. They usually need to also go through different steps on how they validate thei...

Just going back to TMV, its less specific for low variation, but rather determining whether that variation is consistent for different users. There is always going to be tests that have a large bias a...

Not all design inputs are necessarily related to some performance output. For some requirements such as color or force, there is an output that can be related to manufacturing or test related value. F...

I actually have a large amount of experience with test method validation as I recently completed my labs validation for our non-compendial testing. Test method validation is not needed for standardize...