Medical devices are expected to operate safely and effectively throughout their entire lifecycle, not just at the point of regulatory review before marketing authorization. However, it proves to be quite challenging in practice for most device manufacturers to ensure continued safety and effectiveness of their device during the post-market phase.

There are two main reasons for this experience in our industry.

First, the post-market phase of the lifecycle of a typical medical device is far longer than the pre-market phase. Typically, a new product development cycle may last a few months, or at most a couple of years. In contrast, the post-market phase typically spans years - even decades - before a device reaches the end of its lifecycle. Device manufacturers operating under intense competitive pressure prioritize their resources on rapid innovation, and launching new products at accelerated timelines, rather than on currently marketed products generally considered to be in a "maintenance mode". As a result, most devices in the post-market phase receive very little technical support unless there is a crisis due to a major safety issue in the field leading to a significant regulatory action.

Second, most organizations lack the infrastructure and expertise for early detection of safety and performance issues before they become a raging fire. Even when quality issues are reported back from the field, there is a tendency to apply a quick fix, rather than address the deeper, underlying problems. CAPA, or Corrective and Preventive Action, is a broken process at most medical device organizations frequently cited in FDA inspections and warning letters for lack of adequate procedures and questionable effectiveness. 

This is not the problem of "procedures" - we have plenty of them in our quality systems.

We don't have a compliance problem. We have an effectiveness problem.

What if you could set up and operate a highly efficient post-market surveillance process that could help detect potential issues early and facilitate timely action through tight integration with other processes of the quality system? 

What if this process also provided valuable feedback to your R&D teams so they could improve robustness of the designs of the next generation of devices? 

What if it could provide improved visibility and actionable intelligence to your executive team so they could deploy a more flexible resource allocation model and build new competencies?

This is why I am launching a hands-on workshop to help you master the post-market surveillance process. 

Here are the 5 learning objectives of this workshop:

1. Understand regulatory requirements
2. Learn about data sources and analysis methods
3. Learn how to detect and evaluate potential safety signals
4. Learn when and how to update the risk management file
5. Learn how to set up an efficient operating model

I have distilled years of industry experience building and operating these processes in a 4 hour, live, interactive workshop to help you master both fundamental and practical aspects of post-market surveillance. You will learn by doing as you apply the fundamental concepts to a real-world case study in a small group activity. Each workshop session is limited to only 10 attendees at a time to facilitate a robust discussion of real world challenges and best practices. If you pass the final quiz, you will also receive a certificate of competence. 

Ready to boost your competence in post-market surveillance? Click below to register for the next session!

Post-Market Surveillance Workshop - Register Now