Depending on the size of the company, its resources and number of projects the company holds can influence the best type of organizational method. For smaller businesses a project bases organizational structure I think works best. Project organizational structure refers…   Read more»

I agree with this post that labels should only be used as a last resort of precaution use. Product should go through immense testing and make sure there are no risk involved in using the product in its intended use….   Read more»

I also agree with the 4th example being a very important aspect of risk management. When a company conducts it own identification of risks and test they try to be very thorough. However, a company cannot identify all risk and…   Read more»

The cost of regulation I believe is just. Companies pay millions of dollars in applications and fees in the process of releasing their product. These expenses pay for testing and regulations processed done on the product,and also to the subscription…   Read more»

I have not been part of designs review in industry. However, last year a group of BME students and I applied for a URI grant and wanted to start our own project. We had design review meeting for each stage,…   Read more»

I am currently Senior at NJIT taking my Capstone class, which is our senior design class. The purpose of this class is to simulate real-world medical device processes to produce a product. Our professor look at our Gantt chart to…   Read more»

Design controls designates the application of a proper process or method for the developmend of a product. It is mandatory to implement controls when designing and developing products within regulated industries such as medical devices. “The Food and Drug Administration…   Read more»

I am currently a senior in Capstone. The procedures that we are exposed to when it comes to Customer Needs, Business Requirements and test plan is meant to mimic that of the industry. Formatting that class in more of an…   Read more»

Being preparing for an audit is the best way to tackle an assessment. The first way to prepare is to actively start early. As DHF is being processes starting your traceability matrix from day one will make is a lot…   Read more»

Taking minutes is an important aspect of meetings. The biggest legal reason of minutes is that it can be considered as a legal document. The minutes contain the action of the company and important action details. This means that this…   Read more»

I agree with the two post above. There are set guidelines when it comes to the ownership of the intellectual property. However, documentation is always key when it comes to this issue. I believe that the ownership falls directly to…   Read more»

I do think that having placebo-controlled trials are ethically sound and necessary. There are guidelines place with a huge emphasize on when a person should be placed in a trial. The well-being of participants should be considered, and whether or…   Read more»

A double-blind experiment is an experimental method used to ensure impartiality. When both the researcher and the patient are ignorant to the actual ingredients, therefore the trial is completely unbiased. I believe this method is a better way to carry…   Read more»

This video was indeed very entertaining and connected very well to the comic strip. Each department in a company has people with different backgrounds. An R and D engineer might interpret a customer need and tackle a problem in a…   Read more»

This product and marketing method might not connect too well with the topic, however education can be seen as a product and search engines as a platform to market on. Google makes a lot of money by AdWords and many…   Read more»

Two strategies that work well for medical device companies are direct marketing, and coordinated content streaming. Marketing directly to clients and other corporations is one of the best methods for medical device companies. Most products developed by these companies are…   Read more»

This question can have vastly varying, subjective answers. For example, a person in my demographic might not have the luxury to turn down a job offer. The first demographic being a recent grad. Many recent graduates have a dream job…   Read more»

Courts have the right to pierce a company’s veil when there is something illegal or any form of wrongdoing that occurs that the corporation is a part of. In total, I think there are three big reasons why courts may…   Read more»

With the perspective of starting or owning a medical device startup, I would prefer an LLC. The inventor can assign their patents to their LLC. You can do the registration without an attorney, the filing fee for an LLC is…   Read more»

Improving the Quality departments is always an important decision. The biggest would be to track mistakes, keeping a paper trail and enhanced data transparency. This will help with not repeating mistakes and if there is any form of auditing occurring,…   Read more»