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…   Read more»

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 company, went to a  trip to Hawaii for being a top performer…   Read more»

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 protected information. Pay attention to the time period for confidentiality and…   Read more»

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 access helps fund this work. However, it can be challenging, especially…   Read more»

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 lot of money that may seem like its being “wasted”…   Read more»

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 because it helps visually break down the root causes of…   Read more»

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 meet strict design standards and work effectively in…   Read more»

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 the reliability and safety of the final product. Recording all…   Read more»

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 up enhancing the user’s experience. Also, in regulatory compliance, validated software meets industry…   Read more»

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, which may lead to safety risks or issues when trying…   Read more»

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, and performing tests to verify a products ability, they can confirm that the design meets user…   Read more»

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 outputs but guide multiple outputs . In these…   Read more»

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 age, ethnicity, and health conditions, which can show if the…   Read more»

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 or placebo, they could possibly interpret patient responses. This bias is…   Read more»

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 complex ways, so testing helps ensure they work as intended…   Read more»

From what I learned in my own family business this is a tricky process. Although they did not own sole-proprietorships after doing research I found there are some ways to work around this. Convert to an LLP and then workout…   Read more»

I would pick an LLC and I currently am an owner of a few LLC’s due to some specific reasons. Firstly let me briefly explain that my friends and I started a merchandise company and we registered it as an…   Read more»

Hi knd26.First off, I wanted to say that I liked the curiosity that you brought with this post as it made me wonder the same thing. I feel as if the term business could mean so many things and it…   Read more»

This was a very interesting point that I had never had to deal with prior to reading this discussion. If the complaint is that there is too much precision required than there are a few solutions. Firstly, it is important…   Read more»

This was a great discussion to mention. Since we are now entering the age in which the world is beginning to heavily rely on artificial intelligence its is almost certain that it will be in every industry. For example, in…   Read more»