This is definitely a predicament with establishing standards for anything. If any standard is set it maybe seen as too strict or not strict enough dow...

It is the responsibility of the company to fully and accurately inform the end user of the risks associated with their product. Obviously, there are i...

Internal risk is risk associated with the development and standard testing of a product. Its simple to understand some products are inherently more ri...

Validation is the process of ensuring the product you set out to make is correct. This means testing functionality and overall 'benefits' that the pro...

Like those prior, I did not give much thought to meeting minutes prior to working in industry. They are extremely valuable for several reasons, namely...

Factors to consider when designing test methods usually pertain to the products application. Developing the test methods are a direct result of how yo...

I believe that the documentation part of the design control process is the most important. This is not to undermine the importance of any other portio...

I do not have first hand experience with this, but from previous classes I have learned just about what you have stated. Due to complex nature of test...

I am not aware of any company that does this and if they did I'm sure it would be held close to the vest. While this strategy may work in the short te...

I agree with your initial confusion as to why a double-blind is necessary/preferred in some instances. It appears to be an unnecessary step that can p...

Placebo-controlled trials are necessary for assessing the overall validity of a medical device or treatment. Without a blind control, experimental res...

Second to money, I think "need" is the greatest driving factor in participation of clinical studies. When a person is diagnosed with an incurable dise...

Market research is necessary if you have serious intentions of selling a product. Think about a scenario where you reinvent the the toilet. It's bette...

I think in favor of the company's best interest salespeople should be given prior training on the general engineering behind their medical devices. It...

The internet has changed marketing by forcing companies to innovate. Think about the last time you were watching TV. What did you do immediately after...