Risk management is the process of identifying the risk, assessing the risk and taking the steps to reduce the risk. Risk management team which is same people as the project management team will have huge financial savings, there will rapid delivery time as the team members will be working simultaneously on the project as well as the risk management. Involving the entire team in this process by brainstorming sessions and interactive meetings could help to know the importance of it. There could be possibility where the team members may not understand the importance of developing a risk management this could be challenging. There is additional responsibility of managing the risks other than managing the project. Risk management team which is separate, there is more accessibility to more highly proficient and systematic team which will handle the risks in an organized way. Focus will be entirely on the diminishing the risks and improve the productivity. Cons includes the anticipated results may or may not fulfill the expectations. There is possibility in delay of the delivery time and disclosing the confidential data is risky. There is lack of complete control over the risk management.

If the project management team also handles risk management, there will be no room for miscommunication that can occur between two separate departments. Also, the project management team may set more realistic deadlines and put more research into the risks of implementation at the very start. If there is a strict project boundary, the project management team will not have to wait/depend on the risk management team to finish in a timely matter. This could lead to delays the team can't afford.
There is also a benefit to having a separate risk management team. A separate team specializing in risk management may be more efficient, knowing all the aspects, expectations, and time required that come with risk analysis. The undivided attention will also help the team catch all the potential risks the project management team may miss when focusing on other aspects of the project.

I would have to say that the pros and cons of a single, or separate team would vary dependent upon the project. If it were a small project with low risk then there would be more pros in the favor of a single team that handles both project, and risk management. Class I devices are a good example of a project that would only require one team, as they are simple devices with a very low risk. However if there was a much larger project, such as a class III device, a separate team should be made to handle the risks of the device. Class III devices have much more of a risk, as many are invasive, or requiring vigorous testing. Having a separate team may require more time before production/experimentation can begin, but it will ensure that the device is much safer. A separate team allows for a more dedicated investigation, and brings more perspective into what could go wrong.

The team structuring of risk management is dependent on the risk, resources, and time restraints on the project.

As mentioned by jb678, the amount of risk involved in a project will determine the need for a separate risk management team. Risk management is a science, and so for a project with high risk, a specialized team in risk management would be required to ensure the safety of the project. With all the planning work the project team must complete, they could overlook critical risk factors involved in the project that a specialized team wouldn't.

Smaller companies might be limited in their resources to create a separate risk management team. Larger companies will have the resources to hire a highly specialized risk management team; however in some cases they may still prefer not to. A company who values greater team integration of all aspects of the project, a project team would be integrated with the risk management team. This reduces the chances of information getting lost in communication, but may not be as efficient. Also, a lot of planning goes into the project before a Risk Management Plan can be created, i.e., schedule, project costs, performance metrics. Given this, it might be more reasonable to allow the project team that gathers these inputs to work directly on the Risk Management Plan.

Having the project team and risk management team would provide the ability to assess the risks associated with the project better and having a good overall sense of the project would allow the team to predict the outcomes/risks of certain changes/modifications that would impact the other areas of the project. But this would also lead to a pressure on the team for having to complete tasks within a given time frame making it tedious at times for time management.
Separate different teams as project management and risk management would mean a more dedicated team for evaluation of the risk probabilities which would be beneficial in cases when having the same project and risk management teams would not be able to determine a risk in certain cases. However, this would mean more time would be needed for the risk management team to assess the risks for any changes made apart from this having a separate project management and risk management teams would increase the overall cost of the project.

The advantage to having a risk management team internally associated with a project team is the absence of "information silos", in which departments withhold knowledge and information from one another as a norm. By having a risk management team within the project team, individual members from either department can communicate with one another in a more effective manner, which is needed at many stages throughout a project. This is why a risk management team is often part of the project team, because they are kept more in the loop with a project's updates and development. A disadvantage to this is that the risk management team is unlikely to specialize in areas outside of their developing project. This implies that there may be a lack of experience in how to handle matters that may arise down the line. For example, a team that focuses on bone-remodeling products may not adequately know how to address risk involved with pacifying the immune system upon implantation of these products, which can result in excessive costs due to impromptu changes in design.

The external involvement of a risk management team with a project team can be advantageous in the sense that outside knowledge from different fields is likely to be introduced when assessing a project's risk. In the above example, an external risk management team would be more likely to propose various drugs or antibiotics to be applied in conjunction with an implantable bone-remodeling device to prevent the risk of infection. This can not only prevent catastrophe within the project, but also serve as guidance in future bone-remodeling-based projects. The disadvantage associated with having an external risk management team is that they may not be experienced with the project at hand as a result of any potential segregation. This can result in risk management introducing excessive risks and hazards that can take away from a project's budget that will ultimately hinder the project's development.

We've learned about different organizational structures (project, functional, matrix). How might each of these organization types affect the operation of an internal risk management team working on a new pacemaker? What about an external one? In what circumstances would a project manager have to mediate interactions between risk management and the rest of a team?

From what I've seen, there are several pros and cons of having the PM team responsible for managing risks of a project. Because the product managers should be familiar with all of the functions and processes of the different teams responsible for developing the project, they should be better suited to foresee risks associated with a project. In addition, many risks associated with a project have to do with budget and time, both of which are factors the project managers are responsible for managing. However, many potential risks that cannot be foreseen are often detected by members of the team which can potentially be too late to effectively work around.

On the other hand, having a completely separate team responsible for risk management also presents its own pros and cons. Teams focused solely on determining and managing risks of a project may be better suited at detecting potential risks that a project may present, due to the fact that an entire team is a greater resource in comparison to a project management team that is responsible for many other aspects of a project. However, if the risk management team fails to be familiar with the processes of each team associated with the development of the product, the attempts would be futile.

One person working for multiple teams has its own pros and cons such as:
Pros:
It reduces artificial dependencies between projects.
Reduces induced administrativeand context switching overhead.
Increased domain knowledge and team cohesion.
It improves visibility and clarify on progress.

Cons:
Stagnation of technical skill sets.
Boredom and it's morale problems.
Missing value of deep specialities.
Reduces opportunities to learn about other areas with developing a narrow perspective on the work.

From the abovementioned pros and cons it can be seen that working of one person in multiple teams can advantage the company or project but may cause disadvantage to that particular person in some or other ways.

A risk management team is a separate and often independent unit within the project management team headed by the risk manager .The team also develops strategies to mitigate identified risks, applies risk management methodologies and risk analysis tools, and integrates insurance policies of treating prioritized threats with the project management team. The advantages of having risk management team in project team is PM can access the experts when in need because they are in the same project. It is easier to get everyone together to resolve problems related to the project and communication is also easy . However a team dedicated to one project is an expensive commitment can works only on big project. Team have to work on lots of things sometimes parallel this is a disadvantage. If risk management and project team members are different Resources are used efficiently and can move around between projects as needed because dedicated teams suck up resources to work on just one thing. They can limit the number of projects the company can do at any one time, especially when different projects require the same skills.

I think you need to have both. Risk management should be taken into consideration the entire process, but the final approval should be done by different people in risk management. This makes me think of quality teams. They are involved in the process, and they give the final approval (maybe a different person than before). It is more important to have a separate team to ensure that bias is not involved in decision making. However, it is a good thing to have people checking in throughout the process to ensure that you save time from going down the wrong path and backtracking.

Does anyone else have personal experience with this?

I think @mb698 explains it really well as to the importance of the Risk Management Team being the same as the Project Management Team. I also believe that @ jl959 points out an important aspect of the delays that this can cause. However, this can be easily solved provided ample resources. In my own experience, Risk Management for all the currently open projects is done by the people within the Project Management Team who have a sense of all the projects currently open. This allows for multiple points of view to identify risks and how to mitigate them. Then these individuals will schedule a meeting with the respective departments and individuals and discuss the risk each project proposes as well as future steps needed. Through this, all the risks for each project are assessed and mitigation plans have been created in the same meeting. Because of this, the risk management plan meetings are lengthy but have a very good reason and purpose attached to them. If a discussion on a particular risk involves more than the time allotted, that conversation can be taken offline and discussed at a later time. This will help various teams to prioritize the same risks and work on mitigating them, as well as identify low risks that can be accepted. This saves the company time, as well as allows for the Project Management Team members to be aware of outside contingencies that have an effect on their project. With this knowledge in mind, the projects can move along at a faster rate as the individuals know and are aware of the actions being taken in response to the risk presented.

In systems management of medical devices, risk management is a critical process that involves identifying, assessing, and reducing risk. It is important for the risk management team, which is usually the same as the project management team, to work together in order to achieve financial savings and rapid delivery time. Involving the entire team in brainstorming sessions and interactive meetings can help to emphasize the importance of developing a risk management plan.

However, there may be challenges in getting the entire team to understand the importance of risk management. It is also important to note that managing risks requires additional responsibility and there may be a lack of complete control over the risk management process.

One potential solution is to have a separate risk management team that can provide more specialized and systematic handling of risks, which would allow the project management team to focus on delivering the project. However, there are also potential cons to this approach, such as the anticipated results not fulfilling expectations, delay in delivery time, and the risk of disclosing confidential data. Overall, risk management is a critical process in the systems management of medical devices, and it is important to weigh the benefits and drawbacks of different approaches in order to effectively manage risk..

While I understand that in the end it would save the company money to have the risk management team be the same as the project management team, I do not think that this would always be the best course of action. I think that depending on the project, there could be some conflicts of interest. It could happen that a risk be overlooked by the PM team if there is a serious time crunch or pressure for the task to reach a certain deadline. Also, I agree with my other peers that have mentioned that having a separate team spreads the workload out more so that everyone could focus more on their specific tasks for the project rather than doing everything at once. I do see however, that another pro to having the same team do both is that tasks could potentially move faster as you are relying on less people to get the documentation done.