The AdvaMed and DOJ oversight has become so strict since scandals have become large-scale and public. One example is the 2007 orthopedic device kickba...

I think the real issue with defining what “modest” means is about how the gifts to the physicians are functioning on a psychological level. Something ...

I agree with what everyone has said so far. However, I think red flags can appear before you even look at the deliverables or compensation. The compan...

I think a key issue in integrating Design Controls and Project Management is the lack of continuous feedback loops between the two. The distinction be...

I agree with the points raised by everyone so far. Addressing concerns to someone higher up is very daunting since relationships are at stake and you ...

  I agree with what everyone has said so far. Another way to make a matrix organization is to build predictability into the workflow, along wit...

I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add ...

I like how everyone emphasized how important structure, preparation, and inclusion is in risk management meetings. I want to talk more about the forma...

Everyone has brought up excellent points about Poka-Yoke and how it reduces errors on the production floor. However, something that no one has touched...

I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To ...

I think everyone made great points regarding documentation, calibration, and clear communication between the Original Equipment Manufacturers and the ...

I agree that the Therac-25 incident changed how we think about design controls; however, I think that the next "Therac moment” might come from overcon...

I am in agreement with what everyone has said so far, especially regarding the points about how collaboration and regulatory boundaries are imperative...

I agree that verification and validation have distinct purposes that keep the design controls objective and therefore reliable. Verification makes sur...

I liked the point regarding maintaining consistent QC and QA in transferring design control. I also agree that there is great importance in maintainin...