As mentioned earlier replies, Organizational Process Assets (OPA) refer to the plans, processes, policies, procedures, and knowledge bases that are specific to an organization. OPA can come from vario...

An example of late Finish: Rare genetic disorders require the creation of gene therapy, which involves complex research, pre-clinical trials, and extensive testing to ensure safety and efficacy. Ther...

I want to give my opinion about this subject with an example. A company is designing a new medical device, such as a specialized prosthetic limb. In their plan, they estimate the time that will be req...

In this subject, success in any project results from a collaborative effort between the team members and stakeholders. Stakeholders who possess significant influence and resources can play a crucial r...

As a PhD student, one of my biggest challenges is running experiments, especially when using a new protocol. I can never be 100% sure that I will get accurate and correct results before my deadline. E...

This is a good question because as a Ph.D. student, I always have a concern about the privileges that I may have in the future as a part of a project member. Generally, I believe that individuals with...

Project sub-plans play a crucial role in the successful execution and completion of a project in project management. From my perspective, resource allocation and risk management are two important comp...

I agree with you regarding managing the secondary component of a combination product; it can be challenging, especially if the team and its manager lack experience in that area or they need more knowl...

Misclassifying a medical device can result in many issues and complications and pose a risk to patients and healthcare providers. I think the most significant threat is to the patients who will use th...

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, an...

@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...

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 ...

@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...

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 ahea...

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 dur...