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Forum Replies Created

RE: Non Compete Agreement

Posted by: @dbonanno1 Something that is related to this lecture that was not talked about is a "Non Compete Agreement". Usually bigger companies will make you sign a non compete agreement before you ...

In forum Consultants and Legal Basics

4 years ago
RE: Restrictions for physician's gifts

Posted by: @ljw3 I'd like to add that criteria for giving and receiving gifts often applies to both sides in a lot of company policies. Specifically, my company's policy is that I am not allowed to r...

In forum Consultants and Legal Basics

4 years ago
RE: Consultants in the Medical Device Industry

Posted by: @traceymraw I have not worked in a company that has hired consultants, however I think consultants would be most on short term projects. If a project requires extra people working on it or...

In forum Consultants and Legal Basics

4 years ago
RE: What is a risk management file?

Posted by: @quanzi A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Risk Management Mistakes

This thread is loaded with some of the most common mistakes in risk management. Here are the top five that I have been able to find: *A lack of security & business alignment *Limited visibility *P...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Risk Management Tools

Posted by: @pjf22 When performing the Risk Assessment of a new medical device, I think all three tools serve a purpose and can potentially identify risks that the other do not. I also believe that ea...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Minutes for meetings

Minutes are very important. Especially on a day when you're just out of sorts. Even before zoom people would zone out on meetings, make lists to get them through the rest of the day, plan dinner, etc...

In forum Introduction to Design Controls

4 years ago
RE: Design Controls in the other countries

Posted by: @zbw2 China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical devic...

In forum Introduction to Design Controls

4 years ago
RE: What are Design Controls?

Design controls are how the FDA check that the medical device has been developed safely. It also ensures that the product you have placed on the market (or are attempting to rather) has been well tho...

In forum Introduction to Design Controls

4 years ago
RE: Informed consent: What if Henrietta Lacks checked No for research use?

This thread assuredly posses an ethical dilemma. My goodness, what to choose. At the end of the day, it is likely that the next Henrietta Lacks has, in fact, chosen to keep their tissues out of the ha...

In forum Clinical Research Basics

4 years ago
RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

Hi @llefevre! You've giving a wonderful overview of why placebo is used as well as the fact that it is not harmful in anyway to the patient. Coming from the perspective of the COVID trials, I do thin...

In forum Clinical Research Basics

4 years ago
RE: Discussion Topic: Having a "clinical background"

Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or oth...

In forum Clinical Research Basics

4 years ago
RE: S-Corp vs C-Corp

Posted by: @hm243 Most known companies as stated above, follow C-Corp setup, while very few follow an S-Corp. The major difference between the two types of corporations is the taxation. With C-Corp, ...

In forum Business 101

4 years ago
RE: Accepting job based on company.

Posted by: @sahitya-sadineni After watching the videos from this week's lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position...

In forum Business 101

4 years ago
RE: Family Businesses

Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pa...

In forum Business 101

4 years ago
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