Post-Market Surveillance (PMS) & Post-Market Regulatory Intelligence

Scientific evaluation of real-world device performance, emerging safety signals and continued benefit-risk acceptability.

Specialized Post-Market Surveillance for Medical Devices and IVDs

Post-Market Surveillance is a continuous, evidence-driven process that extends beyond conventional complaint handling and vigilance reporting. It requires manufacturers to systematically identify, evaluate and interpret post-market information to verify continued device safety, clinical performance and conformity with applicable regulatory requirements.

ELLECOM provides specialized regulatory and scientific support for the development, implementation and evaluation of risk-based PMS systems, integrating product-specific surveillance strategies, clinical evidence assessment, regulatory safety intelligence and lifecycle risk management.

Our approach focuses on translating post-market findings into scientifically justified conclusions, traceable regulatory decisions and appropriate updates to Technical Documentation.

  • Development of device-specific PMS strategies considering intended purpose, risk classification, technological characteristics, clinical application, known residual risks and available post-market experience.

    ELLECOM supports the establishment of structured surveillance methodologies, including data source selection, monitoring frequencies, performance indicators, statistical evaluation methods, escalation thresholds and defined responsibilities.

  • Systematic identification and critical evaluation of adverse events, recalls, Field Safety Corrective Actions (FSCAs) and emerging safety information reported for comparable medical devices.

    ELLECOM supports documented searches of international regulatory databases, including FDA MAUDE, FDA Recall, BfArM, Swissmedic and Health Canada.

    Retrieved findings are assessed for technological and clinical relevance, reported hazards, potential patient or user harm, failure mechanisms and implications for the manufacturer's risk management documentation.

  • Evaluation of complaint frequencies, non-serious incidents, expected undesirable side effects and product performance deviations to identify statistically significant changes in the device's safety profile.

    Our assessment approach considers exposure-adjusted event rates, appropriate statistical methods, predefined thresholds, historical performance and the clinical significance of observed trends.

    Findings support decisions concerning additional investigations, risk reassessment, corrective actions and applicable regulatory trend reporting obligations.

  • Continuous appraisal of relevant clinical or performance evidence obtained through scientific literature, clinical experience, registries and post-market follow-up activities.

    ELLECOM supports the identification of emerging clinical risks, evidence gaps, changes in the state of the art and potential discrepancies between expected and observed device performance.

    Results are integrated into Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), PMCF/PMPF documentation and benefit-risk assessments, as applicable.

  • Systematic evaluation of whether new post-market findings affect previously identified hazards, estimated risk probabilities, residual risk acceptability or the overall benefit-risk determination.

    ELLECOM supports traceable linkage between PMS findings, the Risk Management File, clinical evidence, risk control measures and applicable General Safety and Performance Requirements.

    Where necessary, evaluations identify the need for additional risk controls, product modifications, labeling revisions, further clinical investigation or corrective actions.

  • ELLECOM assists manufacturers in addressing post-market regulatory obligations across the European Union, Switzerland, the United States, Canada, the United Kingdom and Australia.

    Our support includes the assessment of market-specific vigilance requirements, reportability criteria, regulatory timelines, post-market documentation and applicable communication obligations.

    Particular emphasis is placed on maintaining an integrated global surveillance framework while preserving the distinct legal requirements of each jurisdiction.

Do you have a specific question about Post-Market Surveillance?

Whether it’s about PMS planning, product safety database assessments, clinical evidence evaluation, PMCF/PMPF, trend analysis, PSUR preparation, vigilance reporting, or benefit-risk reassessment, ELLECOM's regulatory specialists are here to support you.

Contact us to discuss your Post-Market Surveillance requirements and how we can support your device's continued safety, performance, and regulatory compliance.