Analysis of post-market data is critical to ensuring continued safety and effectiveness of our medical devices. It is also a requirement of ISO 14971:2019. A common practice in the medical device industry is to establish a structured post-market safety surveillance process for this purpose. In part 1 of a live discussion series on post-market surveillance, we focused on different sources of data that may be used in this process. 

Highlights from Episode 6: Data sources for post-market safety surveillance

Check out the video below which opens our discussion with a brief slide presentation on this topic. 

ISO 14971:2019 requirement is to collect information, not data. In Clause 10.2, the Standard requires that information from various sources be collected for review and appropriate actions. There is no requirement for a specific source or type of data to be collected. As a result, it is very important to be clear about how each source or type of data helps you collect the type of information needed to help facilitate the key decisions in your post-market safety surveillance process. 

Purpose of post-market surveillance

Sure it is a regulatory requirement, but it helps to keep the big picture in mind! According to ISO/TR 20416:2020, post-market surveillance serves the following three main purposes:

1. Monitoring medical device safety and performance
2. Meeting regulatory requirements
3. Contributing to life cycle management

 Source of data used should be aligned with these key objectives to ensure your post-market surveillance process is effective. 

Check out the video above where talk about a variety of issues related to this topic and comments/questions from the attendees:  

• ISO 14971 requirements - types of information to be collected
• Data vs. information
• List of potential data sources
• Use of AI/ML techniques for data mining
• Vigilance vs. Surveillance
• What is the purpose of post-market safety surveillance? 
• Data type, quantity and quality 
• 3 stages to consider for data quality 
• Challenges in coding of complaints
• Understanding limitations of data 
• Why a new product may require a different approach 

Join our weekly live discussions!

In these weekly discussions, we focus on specific questions or topics that practitioners of risk management find challenging from a practical, day-to-day point of view. Our focus is not on regulatory compliance, but on sharing common problems and best practices. 

These sessions generally last for about 30 minutes. We open with a short slide presentation to introduce the topic or a specific question of interest. You can participate by sharing your question or comment via live chat at any time. However, there are a few key points to note:

• This is an open forum; therefore, do not share any proprietary or business sensitive information
• Our discussion is meant to share information and knowledge purely for the purpose of education

 How you can participate

These discussions will occur via live streaming on LinkedIn and YouTube. If you already follow us on LinkedIn or YouTube, you will get a notification as soon as we go live. Otherwise, connect with us here on the Achieve LinkedIn Page or subscribe to our YouTube channel. During the live meeting, you can use the chat/comments section to ask a question or share comments and best practices. 

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