Validation and verification should take place from the early to the final stages of our product lifecycle and even after the release of the final solution. The most commonly used methods are surveys/q...

Specs is determined during the test of the product accordingly to that the specs is also upgraded. As the product is fabricated there will be chances of some specs getting destroy in the manufacturing...

Quality plan itself defines the quality of the product, which includes certain policies, documentation, procedures and tests for the medical devices. As the medical devices already overcomes with many...

The medical device is generally categorized in three class:- class 1( Low moderate risk medical devices), class 2(low to moderate risk medical devices), class 3(moderate to high risk device). The cate...

Huge investment needed in medical device. Some of the small companies collaborate with each other for making a medical device. For instance, Medtronic are taking small companies like covidien just mak...

There are certain protocols given by FDA, Every manufactures should go through the protocols. The main purpose of the FDA is for safety measures. Even though, there is a flaw in the design of the prod...

From my experience in Medtronic, My job was totally functional based system. I was a biomedical service engineer. I had to do certain tasks in a particular day. If there's a emergency case in the hosp...

In order to initiate a big project, starting base level of that project should be a perfect team which plays a crucial role. For a perfect team, needs a perfect manager (leader). Team is like pyramid ...

I think both interpersonal skills and technical skills are important in the biomedical field. For instance, If a engineer makes a medical device gradually he would be having more technical knowledge o...