There are design controls in most countries that design and manufacture medical devices. There are all specific to their particular country and must follow the standards given by that particular count...

One approach that I have seen companies marketing their product is through partnerships with larger more recognized companies. This allows for the product to be seen by people who may already follow t...

In the industry there are indeed many products that can be discovered based on project needs. The Rees system is a product that is leaned about just by googling what is needed for monitoring equipment...

There are a lot of interesting points made above which made it hard to make a decision. But from my research I would go with an LLC. As a mid sized company you can start as an LLC and change it to a I...

Going through all the posts in this tread I agree with the majority of what everyone is saying- that I would not turn down a position based on the type of company. I would focus on the role and the ki...

Public companies have shares that can be publicly traded in the stock market. Private companies do not have stock that can be publicly traded. One of the advantages of a private company is that Privat...

I think that inmost departments that are impacted by quality there is usually not enough focus on the big picture. In most departments the main focus are the goals of the particular department. While ...

I currently work in manufacturing and everything we do is review by Quality. Our department has a good relationship with QA who reviews our batch records. This may just be so due to the fact that manu...

The article I looked at stated that the IOM report on the 510(k) process contains broad recommendations that may have significant consequences and impacts on the medical device industry. Specifically...

I read an article about some rumors that Apple is trying to come up with a watch that continuously measures the blood glucose level. In the early 2000s, the FDA approved a device called the GlucoWatch...

Based on my research, the FDA started regulating tobacco in 2009 by the passage of the Family Smoking Prevention and Tobacco Control Act. What I found interesting is that the Family Smoking Prevention...

I do not have any personal experience working with a company where the study itself was outsourced but I do have experience seeing a vital part of the company being outsourced. At my first job the He...

In the Industry research has a shorter time limit as there is time ticking and there is much more pressure on making it work as it has to be sold and make money otherwise the company is at a loss. In ...

As mention, for testing in biocompatibility, the testing should follow ISO 10993. However, depending on the product there are various other testing that needs to be done before the procurement of any ...

I had worked in a research lab on TBI when we used a blast tube to collect data on pressure being applied to the brain. One of the issues that we experienced was the amount of pressure that were actua...