Medical Device Post-Market Surveillance (PMS) is a requirement of ISO 13485:2016, ISO 14971:2019 as well as jurisdictional regulations; equally, though, it just makes good business sense. PMS allows the manufacturer to gain greater understanding of how their device is performing once it is on the market and it provides real-life data to support safety and efficacy claims. Furthermore, the manufacturer is able to use the valuable feedback from post-market processes to identify any actual or potential deficiencies, highlight possible areas for improvement, and support decisions to maintain or enhance their product’s quality and patient safety.
This webinar aims to explain what PMS is and identify the responsible parties involved in the data capture and surveillance activities. It will further provide an overview and comparison of regulator expectations when it comes to the main jurisdictions of the US, Europe and Australia. Finally, there will be a discussion on how manufacturers can (and should) use their Quality Management System processes to support the execution and management of PMS activities.
Key learnings:
- What PMS is
- How global medical device regulations influence PMS activities
- Best ways to efficiently and effectively implement PMS activities within an organisation
