Forum Replies Created
RE: Restrictions for physician's gifts The fact of the matter is that whether its done by the books or not, bribery can be done very easily. Paying for a spouse's dinner? That's the least that a company can bribe someone if they wanted to.... |
In forum Consultants and Legal Basics |
8 years ago |
RE: Written Agreement v/s Verbal Agreement I disagree with most of what people are saying. Oral contracts are not difficult to prove as long as there is just one witness. Oral contracts are just as binding as written contracts. Although there ... |
In forum Consultants and Legal Basics |
8 years ago |
RE: Discussion Topic: Course conclusion and impressions This class has helped me realize that my initial desire to work in RD is still what I want to do with my career. This course does not go into any actual research of new devices, and why would it. That... |
In forum Consultants and Legal Basics |
8 years ago |
RE: Organization Type vs. Effectiveness I think that the functional org structure is the most effective structure. This way, you can hire experts in their respect fields who don't need to know too much about other parts of the company. Gran... |
8 years ago | |
RE: Forming a Project Team I think it depends at what stage of the company you are in. For example, an RD team doesn't necessarily need to have that great of a relationship or have an immense amount of trust between them. Their... |
8 years ago | |
RE: Organization types of medical devices? I think if I were to start up a company, I would try to go with a structure similar to the divisional market based org structure. As stated in the article, this is structured for a specific niche of ... |
8 years ago | |
RE: how far is "As Far As Possible" I think what it comes down to is essentially the honor system. It may sound quite counterproductive because, of course if you give companies an inch, they'll take a mile. However, if something during ... |
In forum Risk Analysis for Medical Devices |
8 years ago |
RE: Discussion Topic: Risk Management, Risk Analysis As I understand it, dealing with risk is split up into three different categories: Risk Analysis: Risk analysis is simply a definition of risk. Basically, if we do x, y and z may occur. Risk Assessmen... |
In forum Risk Analysis for Medical Devices |
8 years ago |
RE: Risk Identification Yes I was going to mention the SWOT analysis. Preliminary risk assessments are hard to quantify sometimes, so there are many times when the best way to assess each risk is to go back and evaluate what... |
In forum Risk Analysis for Medical Devices |
8 years ago |
RE: Making up tests for design verification and validation One really important test is a fatigue tests and heat test. A the fatigue test is essentially a device that will put a certain amount of cyclic loading to the device and will determine how many of tho... |
In forum Introduction to Design Controls |
8 years ago |
RE: Minutes for meetings When I was the president of a club during my NJIT undergrad tenure, the secretary of the club introduced the concept of minutes during our weekly e-board meetings. I didn't really understand the conce... |
In forum Introduction to Design Controls |
8 years ago |
Customer Needs, Business Requirements, Test Plan This week's discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the... |
In forum Introduction to Design Controls |
8 years ago |
RE: Design Verification & Validation The verification refers to the process that deals with evaluating the customer needs and "verifying" that what the scope is focused in on is based on the customer needs. Validation refers to the proce... |
In forum Introduction to Design Controls |
8 years ago |
RE: Important Part of DDP Thanks for this post. I think the scope management is the most important, not to say the others are unimportant, but understanding what needs to be done in the amount of time given is the best way to ... |
In forum Introduction to Design Controls |
8 years ago |
RE: Design Controls for Legacy Combination Products Personally, I think that this topic should be considered with the famous motto "If it ain't broke, don't fix it" . Obviously, these documents and the protocol to make all these devices safe and effect... |
In forum Introduction to Design Controls |
8 years ago |