Forum Replies Created
RE: Risk Management Team =/= Project Team In a perfect world, this would not be an issue. However, the personal convictions and motivations of the risk management team can affect the validity of their results. In order to keep the risk manage... |
In forum Risk Analysis for Medical Devices |
3 years ago |
RE: Validation vs Verification I currently work at an industrial manufacturer; I have had experience with both validation and verification during my short tenure at this job. We manufacture industrial burners for various applicatio... |
In forum Introduction to Design Controls |
3 years ago |
Initializing Design Controls Entering a company with a strict set of standards already set is a blessing and a curse. Oftentimes existing standards slow down workflows and do more harm than good. If you were a manager trying to r... |
In forum Introduction to Design Controls |
3 years ago |
RE: Minutes for meetings As has been repeated time and time again, meeting minutes can save the team lots of trouble in terms of miscommunication, legal issues, and design traceability. During my time in various groups, those... |
In forum Introduction to Design Controls |
3 years ago |
Different Standards for Design Controls As Dr. Simon mentioned during the lectures this week; companies often interpret the standards outlined in ISO 13485 & 21 CFR 820.30 in a manner that suits them the best. Some may include a whole s... |
In forum Introduction to Design Controls |
3 years ago |
RE: Design Controls In order to ensure a high quality product; all projects would need to be properly documented and researched. Standards should be followed in order to ensure ease of reading and ease in finding documen... |
In forum Introduction to Design Controls |
3 years ago |
RE: Design "Overvalidation"? I 1000% believe this occurs more often than we all think in every industry. At my previous job, I worked a lot with a certain ancient telecommunications company. As a contractor, we had access to thei... |
In forum Introduction to Design Controls |
3 years ago |
RE: Double Blind Vs Single blind Study A lot of studies have to deal with topics that may be controversial or at odds with some researchers & scientists. The reason these double and triple blind studies are conducted is to completely r... |
In forum Clinical Research Basics |
3 years ago |
RE: Clinical trials for Alzheimer’s disease I did a term paper in my undergrad about this very subject. A lot of the current studies in this space are focused on early detection of precursor markers of Alzheimer's. Similar to prion diseases; Al... |
In forum Clinical Research Basics |
3 years ago |
RE: New Drug/Device: A Clinical Trial is Limited? I assume your question references the first round of commercial patients that the drug or device reaches. These people are indeed in a unique position; at this point, if things have been done correctl... |
In forum Clinical Research Basics |
3 years ago |
RE: External Environment Factors All companies have contingency plans in place to deal with internal and external factors that affect their marketing. Internally; a company should have checks and balances in place to ensure high stan... |
In forum Marketing and Sales |
3 years ago |
RE: Discussion Topic: The Fifth "P" of Marketing This is a bit more sinister than clever, but after the advent of data sharing and collection; all companies have access to our individual wants and desires. The documentary, "The Social Dilemma" on Ne... |
In forum Marketing and Sales |
3 years ago |
RE: Importance of building TRUST as a Sales Rep I wholly agree that sales reps must build working relationships with customers. Without such relationships the sales rep cannot do their job. In theory, the sales rep should be talking to clients at a... |
In forum Marketing and Sales |
3 years ago |
RE: Can Companies Invest in Stock Market? Continuing what @ag2357 said in their post; a lot of companies are built to trade shares using other people's money for a profit. These hedge funds exist to buy and sell assets to make their customers... |
In forum Business 101 |
3 years ago |
RE: Accepting job based on company. In all honesty it would depend on my current financial situation and whatever else I need to consider for that job. It definitely wouldn't make or break a job offer for me, however depending on the ty... |
In forum Business 101 |
3 years ago |