Ensuring the safety of medical products is one of the top priorities of the FDA. The FDA is responsible for promoting and protecting public health by ensuring that drugs, medical devices, vaccines, and other healthcare products are effective and do…   Read more»

@ms2768 This is an interesting topic, especially because I always get confused between Class II and Class III medical devices. Devices in Class II are considered to have a moderate risk level, whereas devices in Class III are considered to…   Read more»

From my point of view and based on my studies, for your second question, One of the great strengths of the PDCA cycle is its effectiveness in risk management. We carefully identify potential risks during the planning phase and develop…   Read more»

There are several differences between drug and medical device from my point of view one of the most important differences is the regulatory approval of drugs and medical devices. The process for drug approval involves extensive testing to ensure safety,…   Read more»

@jbh8 I agree with your statement regarding paying and encouraging team members based on their respective positions and work. However, I am unsure if this approach is suitable for team members working on the same project. On one hand, doing…   Read more»

I just saw the title of this section and thought that I could ask my question, which is related to this topic. In the world of business, companies are always looking for ways to innovate and stay ahead of the…   Read more»

In the context of the biomedical industry, the development and implementation of medical devices is a complex process that requires effective system management. This involves carefully considering regulatory requirements and the need for interdisciplinary collaboration. Effective system management should ensure…   Read more»