When starting a small business, an LLC is a great model to set up the business. As has been mentioned above, it provides liability protection and more control over the business and its operations. H...

When deciding which company to work for, either the company has to be a reputable/well-known one, or the position/work has to be in line with the goals/desires of the individual. Ideally, you have a ...

I did some research on Pfizer. Here are my findings: Current Stock Price: $36.37 Market Cap: $216.13 Billion Revenue per employee: $542.46k (I would like to see a larger fraction of this) Total Asset...

The company I currently work for has a good relationship with its QA/QC departments. The reason for this is integration. All projects that are proposed and piloted are done so while consulting with ...

Quality departments are often seen as standing in the way of innovation or creativity. However, their primary directive is protection. Protecting the company from FDA/NGO intervention. Protecting t...

Ultimately the difference between quality and R&D comes down to who each group answers to. Quality is responsible to the FDA, whereas R&D is responsible to the business. R&D strives to f...

The importance of accuracy and precision when it comes to the FDA stems from concerns over safety. If a device or drug is not accurate or precise, there is no way the FDA can allow that level of vari...

In addition to the list above, it should be noted, that not only is there differing regulations on pharmaceuticals, there are also differing regulations on medical devices. And it is interesting, but...

The FDA is strict largely for the protection of the general public. Without these measures in place, there is a greater ability for dangerous products to make it out into the market. I believe the c...

In order to determine what biocompatibility testing a device needs, ISO 10993 can be referenced. There are various tests and requirements that need to be evaluated for each medical device based on it...

Where I work currently, there was such a failure during the early phase 2 clinical trial period for an investigational drug. The drug had performed remarkably well during animal testing trials. Howe...

Animal models are critical to the advancement of science. They are employed in the development of drugs, vaccines, and even medical devices. They have been used for hundreds of years and will be use...

In a perfect world, managers would have all the technical knowledge that all the engineers under him/her have. This is not realistic or feasible. However, a good manager makes the effort to be invol...

I do not see any scenario in which missing a milestone can be considered a success. I understand that a milestone not being met because "something came up" with respect to safety may seem like a bles...

The primary difference between project management for medical devices and other non-medical companies is the adherence to regulations set forth by the FDA. Due to the fact that medical devices are ul...