Service Description
Beijing EconCare Technology’s Post-Market Surveillance (PMS) Service delivers a systematic full-product-lifecycle solution. Empowered by technology and backed by specialist expertise, it continuously tracks and evaluates the safety, performance and regulatory compliance of marketed medical devices. We integrate an intelligent surveillance platform and a senior expert team to build a dual-track mechanism of active surveillance + passive data collection. This enables clients to grasp real-time product performance, accurately identify potential risks, swiftly respond to regulatory requirements, and drive iterative product optimization.
Core Service Modules
1. Data Collection & Consolidation
• Active surveillance: AI algorithms capture product-related safety signals in real time from global public databases including FDA MAUDE and EU EudraVigilance, as well as social media platforms. Internet of Things (IoT) technology is deployed to access in-use product data such as equipment operation logs and patient feedback.
• Passive data intake: Standardized channels are established to receive proactively reported adverse events (AEs), customer complaints, maintenance records and other information, integrating multi-source data from hospitals, distributors and end users.
• Data cleansing & standardization: Natural Language Processing (NLP) unifies data formats from disparate sources and eliminates redundant data to guarantee analytical accuracy.
2. Dynamic Risk Assessment & Early Warning
• Risk signal detection: Statistical models and machine learning algorithms automatically spot abnormal event clustering, shifting safety trends and potential signal correlations, such as abnormal surges in failure rates of specific device models.
• Tiered assessment framework: Risks are categorized into high, medium and low grades based on severity (fatality, severe injury, minor defects), incident frequency and product attributes, with priority handling assigned to critical risks.
• Real-time alert distribution: Risk notifications together with preliminary analytical reports are pushed to clients via exclusive dedicated portals, clarifying risk points, affected scopes and recommended responsive actions.
3. Compliance Reporting & Strategic Support
• Periodic Safety Update Reports (PSUR): Generate multi-lingual PSURs summarizing adverse event statistics, risk analysis and Corrective and Preventive Actions (CAPA) in compliance with EU MDR, NMPA and other global regulatory mandates, supporting automated official submission.
• Post-Market Clinical Follow-up (PMCF): Design and execute customized PMCF protocols. Real-World Data (RWD) studies verify long-term safety and clinical performance to compensate for limitations of pre-market clinical trials.
• Regulatory response support: Provide full assistance including data traceability, document sorting and rebuttal strategy formulation for regulatory inquiries and on-site inspections to guarantee full compliance.
4. Continuous Improvement & Value Mining
• Root Cause Analysis (RCA): Conduct in-depth investigations for critical safety incidents. Fishbone Diagrams and the 5 Whys Analysis Method identify fundamental defects and deliver systematic improvement plans.
• Product optimization recommendations: Propose design upgrades, IFU revision and end-user training programs based on data analytics results to strengthen product market competitiveness.
• Knowledge base accumulation: Archive risk cases and resolution experience into an industrial knowledge library to enhance clients’ forward-looking risk prediction capabilities.
Service Advantages
1. Leading technology delivering remarkable efficiency gains
• Our self-developed PMS platform integrates big data analytics, AI risk alerting and automated reporting tools, cutting data sorting cycles by 70% and lifting early warning accuracy above 95%.
• Mobile dashboards enable real-time data access for timely executive decision-making.
2. Professional expert team delivering in-depth empowerment
• Our team comprises medical device regulatory specialists, clinical consultants, data analysts and registration engineers, covering the full spectrum of regulatory interpretation, medical evaluation and statistical modeling.
• Customized training sessions (e.g., adverse event coding standards, risk signal identification techniques) are offered to help clients build in-house PMS capabilities.
3. Global compliance with seamless cross-region alignment
• Report templates are dynamically updated to keep pace with evolving regulations including EU MDR, US QSR 820 and China’s Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation.
• Unified surveillance management is available for products registered across multiple regions, reducing the complexity of cross-border operations.
4. Proactive risk control with predictable cost management
• Early risk warnings prevent large-scale product recalls, saving clients millions of RMB in potential annual losses.
• PMCF studies unlock additional clinical value of products, supporting indications expansion and medical insurance catalog inclusion applications.
Client Value
• Worry-free compliance: 100% alignment with global regulatory standards to avoid fines and market suspension risks.
• Risk minimization: Proactive hazard management safeguards brand reputation and patient trust.
• Data-driven innovation: Real-world data insights facilitate product iteration and market expansion.
• Cost & resource optimization: Automated tools and outsourced professional services reduce internal investment required to build an in-house PMS system.
Choosing EconCare’s PMS Service is far more than fulfilling mandatory regulatory obligations — it transforms passive compliance into proactive competitive strength, turning product safety into an unbreakable moat for sustainable corporate growth.
