I think there are multiple levels to the culture that an employee will experience in a company. On the smallest level there is the peer-peer relationship. Then there is the manager-direct report relat...

Medical device development is indeed a unique industry that requires very unique project management and creative decision making in order to comply with regulations, create a functional and effective ...

I have never encountered a non-compete agreement but I have been asked to sign non-disclosure agreements. Does anyone know the difference between the two? From what I understand, NCA is just a one-way...

Additionally, a trade secret only works if no one else comes up with the same idea, recipe, design, etc. on their own. If another company is able to replicate your product without any of their employe...

It is customary in medical device companies to allow for meals with health care professionals (HCP) where the company representative will pay for the meal. There is typically a limit to how much the m...

In the last two years, I have noticed a shift in medical device companies organizational structure and a push from my company's management to transition to a matrix organization with a project managem...

Juggling multiple projects is definitely challenging, but it can be really beneficial to have your hands in several initiative in the company as you can take lessons learned from one project and apply...

I have noticed that in recent times most companies are trying to be more inclusive of diverse perspectives, including younger professionals, although there are definitely still those who feel entitled...

Internal risks are easier to identify and manage than external risks. An example of internal risk can be in the QA inspection method implemented. If the inspection test method has inherent risks (oper...

As mentioned above, there are clear advantages to risk management that makes it absolutely necessary for product development and launch. However, there are some things to watch out for. One issue is i...

Another form of risk control may be in restructuring manufacturing processes. Therefore the risk management is not necessarily redesigning the product, but how it is made, to reduce risk of failure. I...

Typically, several inputs are determined based on the customer needs provided by marketing and the VOC evaluation done by R&D. These inputs are then consolidated to a list that is both extensive e...

Another factor to consider in verification activities is testing conditions that the actual product will undergo. This is not to be confused with validation however, which actually evaluates how the p...

My experience with design verification and validation is that both activities must have strategies developed in the planning phase of the project. For verification, the strategy varies depending on th...

@mmd55 As you mentioned, TMV are important for proving that the way we are testing the medical device is accurate and consistent, ensuring the decisions made about the product from the result of that ...