An NDA is a useful tool when pitching your idea to prospective investors and even when searching for patent attorney's for your idea. By state and federal law patent attorney's would have an obligatio...

An example of kickbacks that happened within NJ about a decade ago involved many of the top orthopedic device companies in the area. Zimmer, Biomet, Depuy, Smith & Nephew, and Stryker (although St...

I do not believe this is an over-restriction in fact the companies do have many loopholes. During undergraduate I worked part time as a clinical research coordinator for a pain management practice and...

Currently I work as a Process Engineer and the organization type I work in is a matrix organization. We have associate directors in our group and a director that oversees several departments and has t...

Organizational type depends on the goals of the company. Larger companies with multiple product lines and established brands would benefit from a matrix organization. In this situation the main advant...

I agree with Ginger that it would be ideal to work with people are knowledgeable and easy to collaborate with. In my current role as a Process Engineer I work in a matrix organization and have to deal...

My current role is that of process engineer at my company, within the manufacturing and science technology division. During this phase of the products life cycle we have to assess risks that arise fro...

The best strategy in running risk management meetings is to ensure understanding of the device. A basic understanding of the device components, it's functionality, and how the end user will be utilizi...

I agree with aaq2 in respect to mitigation being the best strategy for countering high severity risk. I do not agree with the fact that risk acceptance is wise option based off cost of acceptance bein...

I agree with dbonanno1 that you can rationalize failures during the verification process. For example, at work we have a new combination product releasing and I was part of the team conducting verific...

I agree with dbonanno1 that you can rationalize failures during the verification process. For example, at work we have a new combination product releasing and I was part of the team conducting verific...

A successful validation process will ensure that each requirement for a use is fulfilled, essentially end user needs are met. An important aspect of a validation plan is knowing your target customer/e...

As mentioned in previous posts design verification is an important step in design control process to ensure that the inputs are equal to the design outputs. Verification is an important step as the te...

Ensuring that your DHF is constantly updated is the best practice in ensuring that it will have all the necessary documents during an audit. As discussed in the past 2 weeks of class the DHF is a livi...

Insufficient design controls will result in a loss for the company. The loss will occur first off by the product not making it to market and this will result in a trickle down effect. As the time, mon...