Post-Market Surveillance for Healthcare Software
Post-Market Surveillance, or PMS, is vital for ensuring that healthcare software remains safe and fit for purpose after it hits the market. For developers, understanding PMS requirements is essential as it is closely linked to evaluation processes that assess the software’s performance and security in real world environments. This monitoring helps identify any issues that may arise post-launch, and ensures that the software continues to meet user needs and comply with the applicable regulatory standards.
Post-Market Surveillance Plan
The PMS plan outlines how to monitor the product after it is placed on the market. It includes details about the software, regulatory requirements as well as methods for data collection. Ongoing Monitoring After Market Access Once Healthcare Software is available on the market, PMS involves continuous monitoring of its performance through data collection from complaints and literature reviews. This helps identify issues that may not have been apparent during pre market evaluations.
PMS Activities
- Literature reviews: checking for new evidence and incidents related to the software to update the risk assessments process.
- Complaint handling: collecting and analyzing complaints is a must for improving your product’s safety. This includes documenting complaints, investigating their causes and implementing corrective actions.
- Trend analysis: using data analysis tools to identify trends in complaints and incidents.
- Post-Market clinical follow-up: this process collects real world data regarding the device’s safety and performance and helps identify new risks.
- Reporting: regular reports such as the Post-Market Surveillance Report and Periodic Safety Update Reports sum up the findings from PMS activities and assess the software’s safety profile over time.
Establishing a PMS Plan
Developers should create a PMS plan that considers the device’s risk class and includes methods for feedback collection. If your Healthcare Software is a MDSW, collaboration with healthcare professionals and regulatory bodies is most of the times a step that organizations should not miss if they aim for a thorough PMS.
Safety Concerns
When safety issues arise, having established processes for communication and product modifications is mandatory. A well implemented QMS ensures that documentation is updated immediately after changes occurred. In conclusion, Post-Market Surveillance is essential for maintaining the safety and performance not only of medical device software but of Healthcare Software in general.