A NDA is a non-disclosure agreement. While a patent is something that is filed to protect a developing property. In a NDA, the people who have signed it must keep the information confidential and secr...

The risks of starting a new project on just a Verbal Agreement is that there is tremendous room for genuine misunderstandings. The other team may not fully understand the nuances of the contract and b...

Throughout my undergraduate experience, there has never been a class that helped relate what I learned in the classroom to real life. I did not have first hand knowledge of the various opportunities e...

When building a team many people make the mistake of just picking people they know really well. While yes this brings some form of comfortability to the team, the end results might be poor. When worki...

When dealing with a medical device company, the best way to form the company would be through the marriage of a matrix organization and a geographical organizational structure. Because this company is...

The organization I would like to work in should be Project based organization. Something I value is the ability to work as a team on a specific job. And being part of a project based organization, I w...

When looking at risk-benefit analysis, one is basically answering the question "is the risk worth it?" To answer this question a thorough analysis needs to be done on the trade-offs of the product. St...

When dealing with low severity risks it can be deemed worthy to accept the risk. By using the strategy of risk acceptance you can anticipate or adjust for greater profit margins and this should cover ...

There are several ways of managing risk. Being part of a medical device company, it is integral to understand and predict certain risks and dangers the product might face. One form of risk management ...

Design inputs are critical to medical device development. The design requirements can be a document that can prove if the product will have issues or not. Usually, products that result in failure is d...

Whenever production of a product needs to be exported, there are several production issues to look out for. When exporting the production design, it is integral to have strict, concise, and clear inst...

The DHF is an integral part of the project design and development aspect. The DHF must be a set of documents that clearly states the intricacies of the product. The DHF must be continually updated in ...

Design controls are parameters that are vital to the completion of a medical device. These controls are given out in conjunction with the customer needs. In fact, the design controls are put together ...

I have had to make a Gantt chart twice through my academic career. The first time I made a Gantt chart was in high school as a senior. We had a capstone project and in order to keep the team on track ...

Being part of the BME capstone class this semester, many of the criteria and aspects detailed above are something I have encountered and worked on. For my particular project we are working with an out...