Last seen: Nov 22, 2021
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 instanc...
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. T...
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 an...
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 sig...
Organizational structures, in addition to more effective communication and autonomy in a project, provide the handoff of the project from development ...
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 wit...
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...
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 ...
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 c...
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 ...
As said by mcf29, there are many different qualifications that the manufacturer goes through to validate their processes. They usually need to also go...
Just going back to TMV, its less specific for low variation, but rather determining whether that variation is consistent for different users. There is...
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...
I actually have a large amount of experience with test method validation as I recently completed my labs validation for our non-compendial testing. Te...