Post-market Program Management

The Crucial Role of Feedback Processes in Medical Device Manufacturing

The most informative process for any medical device manufacturer is that of feedback.  Post-market feedback provides manufacturers with vital information pertaining to their product and their brand.  While often only focused on problems, such as complaints, much can also be gained from proactively seeking feedback from positive sources as well.  Implementing an effective process to mine and manage all feedback data is paramount to an organization’s success.

Define the type and extent of the surveillance needed.

Set clear goals to be achieved by the surveillance system.

Outline the personnel to be involved and their roles in carrying out the process steps.

Define the types of data to be gathered and the methods for analyzing them.

Assess the risks related to the data collected and implement actions where necessary.

AlvaMed’s team partners with clients to organize information and work efficiently toward system management.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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Post-market Program Management FAQ's

It is vital to ensuring the effectiveness of a quality management system, it is a valuable input to both risk management and design, and it is a source of understanding and achieving customer requirements.

While a complaint system is a major source of feedback, including a proactive approach by seeking out information prior to problems occurring offers a more well-rounded process.

The requirements for PMS should be established according to the risk associated with the device based on its intended use.

Brian Ludovico

Director of Quality Affairs

Schedule a meeting with Brian to discuss how AlvaMed can improve your post-market program management.