Forum Replies Created
RE: Written Agreement v/s Verbal Agreement Hi kbs27,In my past, I once had a verbal contract go bad, leading to a messy lawsuit because key details weren’t documented. I wont get into the details too much but I was not paid for work that I did... |
In forum Consultants and Legal Basics |
5 months ago |
RE: Advamed Guidelines Hi jj52,An unreasonable location for a sponsored event might include luxury resorts or exotic destinations that primarily promote leisure rather than professional development. My father, at his old co... |
In forum Consultants and Legal Basics |
5 months ago |
RE: Advice before signing an NDA Hi merzkrashed,If you are ever in the situation, when signing NDA, carefully review its terms to ensure clarity and fairness. Ensure that the scope of confidentiality specifically defines the protecte... |
In forum Consultants and Legal Basics |
5 months ago |
RE: Expense of Regulations Hi sdl3,I feel as if regulations likely cost money because they are developed by organizations that invest significant resources in research and maintenance of up-to-date standards. Thus charging for ... |
In forum Risk Analysis for Medical Devices |
5 months ago |
RE: To risk manage or not to risk manage? Hi rajamharrison,It goes without saying that risk management is absolutely an essential part of the planning phase. Identifying potential risks early helps prevent costly issues later. Yes, there is a... |
In forum Risk Analysis for Medical Devices |
5 months ago |
RE: Risk Management Tools Hi traceymraw,In the past for projects at work, I’ve used brainstorming and the Fishbone Diagram for identifying and organizing potential risks in projects. I find the Fishbone Diagram most beneficial... |
In forum Risk Analysis for Medical Devices |
5 months ago |
RE: Feeling Safer? Hi elm33,Yes after this week's lecture and learning about validation and verification processes I do feel safer using medical devices. We learned that these steps are in place to ensure that devices m... |
In forum Introduction to Design Controls |
5 months ago |
RE: Design Verification Ethics Hi cem34,It goes without saying that neglecting to record unsuccessful instances during design verification in the name of saving time is a serious ethical violation. This increases risk and reduces t... |
In forum Introduction to Design Controls |
5 months ago |
RE: Benefits of Software Validation Hey jbh8,In addition to decreased failure rates and fewer recalls, software validation improves user trust and satisfaction. This is because validated software ensures reliable performance which ends ... |
In forum Introduction to Design Controls |
5 months ago |
RE: Consequences Of Insufficient Design Controls Hi la82,You are right design control is an integral part of product development, but issues can arise if it’s poorly managed. Without proper design control, specific requirements can be overlooked, wh... |
In forum Introduction to Design Controls |
6 months ago |
RE: Design control and risk management Hi sumayia-chowdhury,Design control teams mitigates risk by implementing a structured, step-by-step process throughout the development of a product. By setting clear requirements, conducting reviews, ... |
In forum Introduction to Design Controls |
6 months ago |
RE: Design Output Hi hodafattel,You are right in saying that inputs usually have outputs, but not always directly. For instance, a DID might specify user needs like "easy to use" or "durable," which aren’t standalone o... |
In forum Introduction to Design Controls |
6 months ago |
RE: What is not seen in Clinical Trials? Hi sn64,Clinical trials may miss long-term side effects, rare adverse reactions, and interactions with other medications due to limited sample size and other factors. Also, they can lack diversity in ... |
In forum Clinical Research Basics |
6 months ago |
RE: Double Blind Vs Single blind Study Hi smitshah,Double-blind studies are critical because they prevent both patient and investigator biases which can affect the study outcomes. If the investigator knows who is receiving the active drug ... |
In forum Clinical Research Basics |
6 months ago |
RE: WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS? Hi amd29,I feel as if clinical testing of pharmaceutical drugs is ESSENTIAL to assess their safety, efficacy, and potential side effects. Unlike medical devices, drugs interact with the body in comple... |
In forum Clinical Research Basics |
6 months ago |