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Postmarket Surveillance Service (PMSS)

Quality remains a persistent challenge in the medical products sector, encompassing medical devices, diagnostics, pharmaceuticals, dietary supplements, and combination products. The consequences of poor quality ripple across manufacturers, patients, employees, and investors, often resulting in financial losses, regulatory penalties, and compromised patient safety. As global reliance on medical products intensifies and personalized medicine becomes more prevalent, the complexities of postmarket quality management continue to grow. This challenge is largely driven by insufficient quality reporting and data analysis infrastructures within many manufacturing organizations.

Regulatory Expectations for Postmarket Surveillance (PMS)

Global regulatory authorities impose stringent requirements for postmarket surveillance (PMS) programs, mandating robust processes for:

  • Complaint Handling and Investigation
  • Reporting Serious Injuries and Deaths (e.g., Medical Device Reports (MDRs) in the US, Vigilance Reports in the EU)

These regulations require manufacturers to:

  1. Proactively collect postmarket data from various sources (e.g., customer complaints, field safety corrective actions, adverse event reports).
  2. Analyze collected data to validate that the product's risk management profile aligns with established safety and performance expectations.
  3. Update technical documentation, including Clinical Evaluation Reports (CER) for medical devices, based on findings from PMS activities.

Failure to implement an effective PMS program exposes companies to regulatory enforcement actions. In the US, deficiencies in Product Complaint Handling are among the top-cited issues in FDA Warning Letters, underscoring the critical importance of this function.

Unlocking the Value of Postmarket Data

A well-structured postmarket surveillance system, supported by adequate resources and advanced analytical tools, empowers manufacturers to:

  • Detect quality issues early and respond proactively.
  • Enhance patient safety by minimizing adverse events.
  • Ensure regulatory compliance, avoiding costly penalties and product recalls.
  • Drive continuous improvement in product design, manufacturing processes, and overall quality management.

By recognizing the strategic value of postmarket data and investing in robust infrastructure, medical product manufacturers can protect patients, strengthen compliance, and build trust with regulators and stakeholders.

Success Story

Complaint Handling for Japanese Medical Device Manufacturer

Our Post-Market Surveillance (PMS) service is designed to deliver measurable value to our clients by enhancing compliance, efficiency, and overall quality management. Below are the key benefits:

  • Confidential and Accurate Complaint Handling:
    We ensure that your complaint handling processes are managed with utmost confidentiality while maintaining balanced and precise language in adverse event reporting and documentation.
  • Proactive Event Representation:
    Our team remains vigilant in how events are portrayed, prioritizing accuracy and regulatory alignment in all communications.
  • Administrative and Regulatory Expertise:
    We bring specialized administrative support paired with deep regulatory knowledge, alleviating the burden on your internal teams.
  • Cost-Effective Resource Allocation:
    Our trained professionals are ready to contribute immediately, eliminating delays associated with onboarding, training, and overhead costs (e.g., health insurance and employee benefits).
  • Informed Risk Management Feedback:
    Through complaint and trend analysis, we provide actionable insights to update risk management processes, including Failure Modes and Effects Analysis (FMEA).
  • Advanced Trend Analysis:
    Utilizing empirically validated data, we deliver more precise and effective trend analysis, enabling data-driven decision-making.
  • Seamless CAPA Integration:
    When recurring trends or systemic issues are identified, we ensure they are effectively integrated into your Corrective and Preventive Action (CAPA) program for timely resolution.
  • International Regulatory Expertise:
    Our team possesses global regulatory knowledge, ensuring compliance across diverse markets and jurisdictions.
  • Integrated Service Support:
    As part of the RQMIS ecosystem, we can swiftly assist with other complementary services, creating a seamless experience for our clients.

Partnering with us means leveraging our proven expertise, dedicated resources, and comprehensive approach to Post-Market Surveillance, ensuring regulatory compliance while enhancing product quality and patient safety.

Postmarket Surveillance Overview

How RQMIS Can Support Your Post-Market Surveillance Needs

At RQMIS, we specialize in helping medical product manufacturers design, implement, and optimize comprehensive Post-Market Surveillance (PMS) programs that meet global regulatory requirements and drive continuous product improvement.

Our approach includes both proactive and reactive monitoring of product use and feedback, ensuring you maintain compliance while enhancing patient safety and operational efficiency.

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Our Post-Market Surveillance Services Include:

  1. Accurate Feedback and Complaint Management:
    • Proper categorization and processing of customer and employee feedback.
    • Effective management of repair processes and product complaints to ensure accurate documentation and resolution.
  2. Serious Injury and Death Reporting:
    • Expertise in Medical Device Reporting (MDR) for the FDA (U.S.) and Vigilance Reporting for the EU and other international markets.
    • Timely and compliant reporting of adverse events to regulatory authorities.
  3. Risk Management Integration:
    • Analysis of complaint trends and integration of findings into Failure Modes and Effects Analysis (FMEA) and overall risk management plans.
  4. Enhanced Trend Analysis:
    • Utilize empirically validated data for more precise trend detection and analysis.
    • Provide actionable insights to identify potential systemic issues.
  5. CAPA Integration:
    • Ensure identified trends are seamlessly integrated into your Corrective and Preventive Action (CAPA) program.
    • Facilitate prompt resolution and ongoing process improvement.
  6. Regulatory Expertise Across Markets:
    • Navigate complex global regulations with the support of our international regulatory experts.
    • Stay compliant with requirements in regions like the EU, U.S., UK, and beyond.
  7. Seamless Cross-Service Support:
    • Easily access other integrated RQMIS services, such as regulatory consulting, clinical evaluation, and quality management support, ensuring a holistic approach to compliance and quality assurance.

By partnering with RQMIS, you’ll benefit from our deep expertise, tailored solutions, and commitment to excellence, empowering your organization to effectively manage post-market activities, reduce compliance risks, and prioritize patient safety.

Want to explore what Post-Market Surveillance, including Complaint Handling and Adverse Event/Vigilance Reporting, looks like in your organization? Our experts are ready to show you.

To learn more please call us at 978-358-7307, or just click the button below.

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