Statistical sampling is required for design verification and validations. If you have worked for a company or written protocols in the past - how have you explained or ensured that the sampling plan ...

From my experiences determining the duration of each task is highly important. Through past projects within industry, I have found that project managers are sometimes over optimistic about how long a...

I fully agree with this. There are various test that can be done to physically test a device. Instron testing to test mechanical properties, environmental testing to test how a product reacts in cer...

To have an adequate Design Control System - one that will pass audits at the minimum, you must have Design Inputs, Design Outputs, Verification, Validation, Design Transfers, Risk Analysis, the DHF. F...

I recently went through an internal audit in which we reviewed the DHF of one of our product lines. There was heavy debate on information within the Design Specification Document (DID). The DID conta...

I don't believe it is completely necessary to have a clinical background to work in this field. To say you need have a clinical background for a role is highly limiting the talent pool that would pot...

From a Big Pharma standpoint in terms of clinical research, it is very money driven and results driven. For example, for a double blind test, the intent is to remove as much bias from the test subjec...

Clinical trials and research is designed to expose a limited sample of subjects to potential new treatments. Human tests of a medical intervention typically pose risk to subjects despite the amount o...

SWOT Analysis for Boston Scientific - Boston Scientific is a global developer of interventional medical devices that target cardiac rhythm management, cardiac and vascular surgery, electrophysiology, ...

I feel this video clearly depicts that there tends to be disconnect from the customer and the supplier. I believe most of this can either be attributed to lack of communication - the customer doesn't...

In China, the country offers Wholly Foreign Owned Enterprises. This is the most popular form of incorporation of foreign companies in China. WFOE allows an LLC company that is owned by foreign to op...

Depends. If you are looking to work in medical devices and it is a well established company such as a conglomerate like Johnson and Johnson, then you don't need to worry about their stability or finan...

As many have mentioned, it highly depends on what type of business you are trying to conduct. If I was creating a tech start up I would most likely go the route of an LLC. With an LLC it will be relat...

What if your favorite company pertains to a cryptocurrency? Can I discuss my evaluation on that?

Interesting that you say "some auditors have the mindset that they must issue an observation or a finding before leaving a plant." I believe ALL auditors have this mindset no matter how good your qua...