How to Conduct Post-Market Surveillance for SaMD

Ben Trombold

Published on: March 3rd, 2025

How to Conduct Post Market Surveillance for SaMD

Post-market surveillance (PMS) is a critical component of Software as a Medical Device (SaMD) lifecycle management. It ensures that SaMD solutions remain safe, effective, and compliant after they’ve been launched. In this guide, you’ll learn the essential steps, tools, and best practices for implementing robust post-market surveillance processes for SaMD.

Why Post-Market Surveillance is Critical for SaMD

Ensuring Patient Safety

SaMD often deals with sensitive medical data and decision-making. Continuous monitoring allows developers to address safety issues and mitigate risks promptly.

Regulatory Compliance

Regulatory bodies like the FDA and European regulators require post-market surveillance as part of the SaMD approval process. Non-compliance can result in penalties or market withdrawal.

Regulatory Expectations for Post-Market Surveillance

FDA Guidelines

Real-World Performance Monitoring: Collect and analyze real-world evidence (RWE) to ensure SaMD operates as intended.
Periodic Updates: Submit periodic safety updates to the FDA as required.

MDR/IVDR in Europe

Post-Market Clinical Follow-Up (PMCF): Continuously gather clinical data to validate SaMD performance.
Vigilance Reporting: Notify authorities about adverse events within specified timelines.

Best Practices for Post-Market Surveillance

1. Use Real-World Data

Collect data from diverse sources, including:

User feedback and complaints.
Data from connected devices and platforms.
Clinical outcomes and adverse event reports.

2. Conduct Regular Safety Audits

Perform periodic internal audits to identify gaps in compliance and performance.

3. Automate Data Collection

Leverage AI and machine learning tools to automate the collection and analysis of real-world data, enabling faster issue identification.

Tools and Technologies for PMS

AI-Powered Monitoring

AI/ML tools can identify trends and potential risks in real-time, allowing proactive interventions.

Cloud-Based Systems

Utilize secure cloud platforms to store and analyze large datasets efficiently.

Collaborative Platforms

Enable seamless communication among stakeholders, including regulatory teams, developers, and healthcare providers.

Overcoming Common Challenges

Data Privacy and Security

Ensure compliance with data protection laws like GDPR and HIPAA when handling patient data.

Resource Allocation

Invest in dedicated teams or outsource PMS to specialized firms to ensure thorough monitoring.

Regulatory Updates

Stay informed about changes in PMS requirements globally to avoid compliance issues.

Conclusion

Post-market surveillance is an ongoing responsibility that ensures SaMD solutions continue to deliver value while maintaining safety and compliance. By leveraging real-world data, automating monitoring processes, and adhering to regulatory requirements, you can enhance the performance and reliability of your SaMD.

For more insights, explore related articles:

FDA SaMD Guidelines: Navigating Compliance

Take the next step in SaMD excellence by mastering post-market surveillance today.