I believe modifying the risk part is the most efficient method for cost down. However, it is impossible to create a device without any risk. Some functions of the device always accompany the risk. Mor...

Post-market surveillance is essential for the most medical device. A company needs to track the performance of its product. It can extend the product's lifetime by constantly giving feedback to make t...

The most impressive hazard event for me was the cadmium poison pollution in Toyama prefecture in Japan in 1912. I still remember this event because cadmium pollution also happened near my grandfather'...

It confused me at first, but I figured out the difference by remembering the different results of Validation and Verification want. Verification is a process to know do you do the thing with the corre...

I believe the meeting recording is essential. I used to attend a meeting that several research teams needed to report to the head of research and development. Each team would give their progress prese...

When a company is preparing the project definition form, the market department should already conclude the requirement of the customer and engineering departments. The project's input is supposed to b...

Every component of design control is significant, and each one relates to others. I believe opinion input and verification are the most important of the nine components of design control. The opinion ...

I don't know or hear of any company that does such things. It's illegal and unethical behavior for a company. The skipping and instead the data would be dangerous for the patient in the biomedical dev...

Both documents are necessary for the project design because they are the basic description for different readers. The advantage of DID document is that the reader can quickly understand the product's ...

I believe the clinical trial is significant for the new device and drug development. Although everything that comes to the clinical trial has the IDE and IRB approved. When the device is required to a...

I want to be a clinical investigator if I attend a clinical trial. An investigator must contact the patient, enroll the subject, set up the following document, and record everything. I will be able to...

Some patients might accept a clinical trial because this therapy might be a new option for their disease. It might also be because monetary compensation can cover other therapy needs. Money is the mos...

I prefer marketing over sales if I want to change my career route from engineering to these two areas. Being a sale is more complex than I thought. Sales need to visit the customer to promote products...

I agree that medical sales should have basic knowledge about their products. But nobody knows everything they sell in the company. So I believe that the training course is necessary. People probably w...

The most impressive advertisement for me is the GEICO car insurance ad. Their mascot is the most iconic symbol for their company. They usually use this mascot as part of their advertisement, which mak...