Managing Postmarket Surveillance for Medical Devices with an ERP

For medical device, equipment, and supplies manufacturers, postmarket surveillance (PMS) is an essential part of product life cycle management. Some manufacturers avoid creating a postmarket surveillance plan until after their products are approved, forcing them to scramble to come up with something before their release dates. Planning at the last minute tends to lead to expensive mistakes that hurt brand reputation, profits and stress out teams. Instead of being reactive, think through postmarket surveillance from the start with an ERP. An ERP makes it simple to manage postmarket surveillance for medical devices, equipment and supplies.

What is postmarket surveillance (PMS)?

Before diving in, let’s establish what we mean by postmarket surveillance. Postmarket surveillance is how you monitor the safety and performance of a medical device that has been released to the market. Analyzing user data or complaint feedback is critical during PMS.

21 CFR Part 822 – Postmarket Surveillance

21 CFR Part 822 – Postmarket Surveillance from the FDA states that PMS is required for Class II and Class III devices that meet any of the following criteria:

    • Failure of the device would be reasonably likely to have serious adverse health consequences
    • The device is intended to be implanted in the human body for more than 1 year
    • The device is intended to be used outside a user facility to support or sustain life

If your device meets these criteria, then the FDA has the power to order your company to conduct postmarket surveillance of your products using a formalized plan under section 522 of the Federal Food, Drug, and Cosmetic Act, in addition to the quality processes you already do.

Even if your device does not meet these criteria, it is still important to conduct postmarket surveillance. After all, no one wants their product to hurt customers or to be involved in a recall by the FDA.

Complaint Tracking and CAPA Management

The main issue in postmarket surveillance is managing complaints from users. An ERP system makes it easy to track complaints and can automatically alert your team if a product hits a certain number of complaints or a certain number of severe complaints. You can also set expectations for how employees respond, meaning you can track factors like how quickly and effectively your team addresses issues. If you need help setting up your ERP, look to an ERP expert like Datix. After 25 years of supporting manufacturers, Datix knows the importance of making ERP simple. Our team uses a business-first approach with our clients, meaning that we take the time to understand your specific needs so that you can maximize your system. Learn more about optimizing your systems with Datix.

Analyzing PMS Data

To take your business to the next level, it is important to do more than simply collect postmarket surveillance data. Instead, your ERP can analyze your data to identify problems or new uses for your product, as well as see how your devices are performing overall. This analysis should be shared throughout your organization to foster proper investigation or research if needed. PMS data analysis should happen regularly as a part of your business processes, even when things are going well. That way, you can identify concerns early on.

Resolving issues quickly can be a difficult challenge, but an ERP makes it easier to streamline complaint response and identify how to speed up response time. Don’t underestimate the power of an ERP. Work with an ERP expert that will continue to support you as your PMS processes improve. At Datix, we work with our clients throughout every step of their ERP journey, from the planning to the implementation and beyond.

Wrap Up

Postmarket surveillance is important, but it is just one factor in managing quality control with an ERP. With Datix, you gain the support you need to manage PMS, quality management, risk analysis, and everything else your business needs.

Read more on Simplifying Quality Control for Medical Manufacturers

Read more on Risk Management for Medical Manufacturers

About Datix

When medical manufacturers are implementing a new ERP or software solution, Datix is the partner of choice. Datix has 25 years of ERP consultation experience and has worked with all the major software applications. At Datix, we will work with you every step of the way so that you see an increase in productivity, customer satisfaction, and profits.

Learn More About Our Mission to Our Clients

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