Kickbacks are a truly frightening example of corruption and illegal preference because it blurs the line of authenticity and faithfulness of a free making decision that is for the best rather than bei...

My dad had gone through this issue during the 2008 financial crisis, so I am familiar with this experience. In his case, him and his coworkers had exceptional leverage with his company to negotiate th...

Non-compete agreements typically barr you from working with a competitor on a similar product that you had previously worked on. In my experience, it was not an umbrella restriction that prevented you...

I prefer the hierarchal organizational structure because it provides clear and coherent structure of what the leadership and continuity of reporting is. My opinion is based on my own experiences, havi...

There are a wide variety of organizational structures, each serving its own benefits and cons that suits their own respective business goals and objectives. Therefore in my opinion, there is no "best ...

Speaking from Nov. 2023, the specifications for Prof. Simon's final project have remained relatively the same. Currently, my team is still in the drafting phase, working to find resources and develop ...

I think the term is meant to signify the balance between reducing risks as much as cost effectively possible for that medical device. The transition from ALARP to AFAP suggests that there is more emph...

In the medical device industry, risk management is critical to ensuring patient's safety and regulatory compliancy of both federal and international governments. Throughout the device's life cycle, po...

Going based off the forum post title question, I think that it is absolutely essential for the medical devices to have risk assessments. Firstly, medical devices and alike are often the frontline trea...

Whether or not a company has good ethical responsibility to put out a good, safe product, they are upmost certainly minded with some sort of fiscal responsibility to make a profit. So they certainly h...

My senior year's capstone or design project was the development of a computational pipeline to help sort and categorize different cell types into its biological classifications. Our market research in...

I think that the team should first have a strong basis of understanding for what is being examined and needed to be defined. Preferentially, the decision should come down to a cross-functional project...

Having worked at a medical device company as a QA intern, I worked on ensuring compliancy with CAPA records, some of which that were opened because of design controls issues. I think largely, CAPA rep...

Design controls are important for any manufacturing or R&D role because it allows it would ideally provide limitations of what is safe enough to be used or allowed in specifications, which is typi...

I think to revise design controls for a medical device, it starts with understanding why the controls are there in the first place, including the history or events that may have lead to the controls b...