PMS audit and Consulting

PMS audit and Consulting

PMS audit and Consulting

Postmarket surveillance regulations or requirements, an area for which many medical device manufacturers may historically have lacked focus, now demands that companies develop more proactive mechanisms to stay compliant and ultimately to keep their patients safe.

The current challenges for manufacturers of medical devices are to:

+ Keep pace with current requirements for postmarket surveillance
+  Be aware of, and to correctly interpret, local requirements
+  Ensure that their Quality Management Systems (QMS) remain compliant with current postmarket surveillance requirements within all countries where their devices are intended to be distributed.

As with many processes, the time and resources required to complete activities are often significantly underestimated. This leads to projects failing to meet target deadlines, which is in itself a serious compliance issue, but is also as important as it often means that less effective processes and more expensive temporary fixes are implemented, putting even more strain on organizational resources and personnel.

The key to avoiding these pitfalls is to establish appropriate processes to ensure that the organization is aware of potential changes and performs appropriate analysis to determine the impact that these will have on all areas of the organization and quality processes. This can be achieved by taking a more proactive approach and planning appropriately.

Eclevar audits the complaint handling, vigilance and medical device reporting systems, including performing an analysis of the postmarket clinical follow-up planning and field action / recall processes to determine the updates necessary to ensure ongoing compliance to regulatory requirements. We work with clients to implement the improvements required and ensures the client remains audit-ready for both notified bodies and competent authorities.

Contact us for more information.

Keep learning

Navigating postmarket surveillance requirements
In international waters and in a changing regulatory climate