A project manager can evaluate the project outcomes and monitor its products. Results of the project can be assessed for their benefits or value, especially as they continue to be used or produced in the post-market phase. Monitoring the products may utilize an ERP system or another system to collect valuable data. The data can go towards post-approval regulatory requirements, design improvements, cutting costs, customer satisfaction, or long-term performance or safety studies. Additionally, a PM can use a Gantt chart to oversee progress. Because a project has a start and end date, new projects or tasks can be developed that are focused on post-market management. 

First, I certainly agree that a PM's role goes past market release to monitoring outcomes and project value. For post-market management, the PM's main role would be to shift to oversight and, more specifically, to translate feedback on complaints/CAPAs/regulatory updates into actionable tasks/projects. Tools like ERP systems would definitely help with this, as the PM would be able to track trends and keep timelines realistic for post-market initiatives. 

If an FDA recall occurs, the PM would again play a critical coordination role. Regulatory would remain responsible for compliance, but the PM should coordinate all departments, manage timelines, and ensure thorough documentation. Your question certainly highlights the PM's role as a "systems integrator" rather than just a scheduler. Based on all of this, do you think PMs should be given a more formal role in post-market surveillance/risk reviews? Or should the primary responsibility stay with regulatory/quality?

The company’s organizational structure can affect the project manager’s responsibilities. The project manager has more power than a functional manager in a strong matrix organization, which can give them control over post-market surveillance or projects related to regulatory or quality. The same applies to a project-based organization where the project manager has authority. They would be the ones corresponding with customers or regulatory bodies and working closely with regulatory or quality team members. However, these responsibilities would fall to the functional manager in a functional organization or in a weak-matrix organization. 

I did a bit of research, and I agree that the PM’s role shouldn’t stop at market release. One added perspective is that post-market activities often function like a series of smaller, iterative projects, and PMs are well-positioned to structure those efforts so feedback doesn’t get lost. Beyond tools like ERPs, PMs can add value by setting up recurring cross-functional reviews and dashboards that connect complaints, CAPAs, and risk management updates into a clear action plan. If a recall occurs, the PM can also help reduce chaos by coordinating priorities, aligning timelines, and making sure decisions and actions are documented consistently. I don’t think PMs should replace regulatory or quality in post-market surveillance, but giving them a more formal role in risk reviews could improve execution. That balance keeps regulatory in charge of compliance while allowing PMs to drive coordination and accountability.

I think that a crucial part of a PM's job post-market release is ensuring that all the proper documentation has been collected and organized, and the PM should, as Sami mentioned, either prepare for post-market activities or help facilitate a handoff to whoever is overseeing the project in the post-market phase. It may also help to write up an evaluation of the project's success against objectives as well as any challenges encountered to help future project team members, beyond the standard documentation the FDA and company requires. The PM should maintain contact with the team and utilize organizational tools such as a Gantt chart to help make sure they keep on top of tasks.

In the event of an FDA recall, the PM should work closely with the team to ensure the FDA instructions are closely followed as quickly as possible to minimize the risk of harm associated with the device. Documentation during this event would also be crucial, to prove that all requirements have been met and upheld.

The PM does indeed still have a role post-market, but it is important to be careful on where that role ends or blur on who actually owns the rights to the completed project. Once a device is created and approved for market use, watching its performance in the market marks the end of the actual project itself, but rather a task overtaken by a separate quality assurance team. In this phase, the PM should not be positioned as an essential member of market surveillance, but rather as a part of the support team when post-market issues arise and corrective initiatives need to be undertaken by the company. 
In the case of an FDA recall, this distinction of the separation of where a PM responsibilities end is even more important. The main communication of the nature of a recall must exist mainly between a regulatory and quality team (I've mentioned in other posts how a PM must be involved with FDA compliance, however this should only be during the actual development of the product). The only time that a PM would get involved is once the recall strategy is defined, the PM can add value by coordinating how it is executed across the team to ensure that timelines and proper documentation to the FDA is provided, as a recall becomes an issues across all development teams that created the product originally.
That's why it is often better to give PM's points where they should step in and engage, rather than remaining a permanent, fixed role during the entire life of the project. This not only allows the PM to take on new projects, allowing the company to move forward, but ensures that the proper accountability is maintained between development and quality assurance. 

There a lot of points already mentioned in this thread that I agree with, especially the shift of the project manager role once a device enters that post market phase. I think an aspect that has not yet been emphasized too much is the PM's role in knowledge retention as well as continuity once a device enters the post market phase. Regulatory and quality teams could take ownership of surveillance activities, but the PM is often uniquely positioned in the preservation of institutional knowledge from the development phase. This could be the original design assumptions, trad offs, risk decisions, etc.; either way, they ensure that the context is not lost over time. Being able to create a structured design intent summarization or post market knowledge sources could help other teams respond not only more effectively to complaints, but to recalls as well in the future. If the event should arise that the FDA recall, this context could be useful and critical in identifying root causes more quickly and avoid redundant investigations.