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 down the line. "As far as possible" should mean withi...

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 instances where not everything can be listed on a b...

Internal risk is risk associated with the development and standard testing of a product. Its simple to understand some products are inherently more risky than others such as a band aid vs. a hip impla...

Validation is the process of ensuring the product you set out to make is correct. This means testing functionality and overall 'benefits' that the product may be advertised with. Verification is more ...

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 keeping track of on going tasks but also apart of...

Factors to consider when designing test methods usually pertain to the products application. Developing the test methods are a direct result of how your product will be used in the future as well as a...

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 portion of design control as they are all equally respon...

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 testing on animal tissues, you're study is susceptible...

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 term to avoid displaying the failures of a product, ...

Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not...

Placebo-controlled trials are necessary for assessing the overall validity of a medical device or treatment. Without a blind control, experimental results will not be able to make an accurate comparis...

Second to money, I think "need" is the greatest driving factor in participation of clinical studies. When a person is diagnosed with an incurable disease whether because of its stage or severity, they...

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 better in every way and only slightly more than the con...

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 will not only help the salesperson recommend the ...

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 your show went to commercial break? You picked up...