Post-Market Surveillance (PMS)

A documented, systematic strategy for gathering real-world data from diverse sources. This is not passive complaint handling; it is an active search for signals.

• Sources: Clinical literature, social media, registries, user feedback, and competitor device reports.
• Objective: Identify emerging risks or usage errors before they result in harm.
• Regulatory Basis: Mandated by ISO 14971 and ISO 13485 as part of the QMS.

The analytical engine that separates statistical noise from genuine safety signals. For SaMD, this often involves monitoring algorithmic output distributions for unexpected drift.

• Statistical Methods: Utilizes disproportionality analysis and trend analysis on complaint data.
• SaMD Specifics: Detecting data drift or concept drift that degrades diagnostic accuracy in specific subpopulations.
• Outcome: A triaged list of potential hazards requiring formal investigation.

The formalized intake, logging, and regulatory reporting mechanism for device-related incidents. This is a legally binding process with strict timelines.

• Medical Device Reporting (MDR): Mandatory FDA reports for deaths or serious injuries within 30 days.
• Vigilance Reporting: The equivalent process under the EU MDR, requiring trend reporting and periodic safety update reports (PSURs).
• Integration: Must link directly to the CAPA system for root cause analysis.

The closed-loop engine that drives continuous improvement. When a PMS signal identifies a systemic failure, the CAPA process executes the fix.

• Correction: Immediate action to contain the problem (e.g., a software patch).
• Corrective Action: Eliminating the root cause of a detected nonconformity.
• Preventive Action: Eliminating the cause of a potential nonconformity before it occurs.
• Effectiveness Check: Verifying that the action taken actually resolved the issue without introducing new risks.

The ongoing scientific assessment of clinical data to verify safety and performance throughout the device lifecycle. This is a continuous update to the initial pre-market clinical evaluation.

• Post-Market Clinical Follow-up (PMCF): Proactive studies designed to address residual uncertainties or long-term performance questions.
• SSCP: The Summary of Safety and Clinical Performance is a public document updated annually for high-risk devices.
• Data Sources: Integrates findings from the PMS plan, published literature, and registries.

PMS data is a mandatory input back into the living ISO 14971 risk management file. Real-world evidence must be used to challenge prior assumptions.

• Hazard Re-evaluation: Are the severity and probability of harm still accurate?
• Benefit-Risk Analysis: Does the clinical benefit continue to outweigh the residual risk?
• New Hazards: Identification of previously unforeseen hazards arising from off-label use or cybersecurity vulnerabilities.