Post Market Clinical Follow Up

Unlocking Insights: Understanding Real-World Product Use to Drive Improvement and Innovation

Discovering how customers actually use your product in practice is essential for ensuring it meets their needs, performs as intended, and delivers value in real-world scenarios. Observing and analyzing customer interactions with your product provides valuable insights that can drive design enhancements, process improvements, and better regulatory alignment.

Key strategies to uncover real-world product use include:

  • Post-Market Surveillance (PMS): Systematically monitor and collect data on product performance, user feedback, and adverse events after market launch.
  • Customer Feedback Programs: Implement structured mechanisms for gathering feedback directly from patients, clinicians, and other end-users.
  • Usability Testing: Conduct real-world usability studies to observe how users interact with your product in clinical or home settings.
  • Field Observations: Work with healthcare professionals to observe product use in actual operational environments.
  • Surveys and Focus Groups: Engage with users to gather qualitative insights on ease of use, performance, and areas for improvement.
  • Data Analytics: Leverage data from connected devices, software logs, and other digital touchpoints to understand usage patterns and identify potential issues.

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After years of development, validation, and controlled clinical studies, your product is finally in the hands of patients and clinicians. However, real-world use often reveals challenges that controlled environments cannot predict. Variations in user behavior, environmental factors, and even inconsistencies in manufacturing (if not strictly aligned with your Device Master Record or MMR) can lead to unexpected failures in the field.

If a failure causes or could cause serious injury or harm, reporting to regulatory authorities in the UK, EU, or US becomes mandatory. In the United States, compliance with FDA requirements under 21 CFR Part 803 for Medical Device Reporting (MDR) is essential. Navigating these regulatory obligations can be complex, but RQMIS’s FDA expert consultants are here to guide you through the reporting process, ensuring accuracy, timeliness, and compliance.

In the most critical scenarios, you may face the difficult decision to recall your product. Regardless of the severity, all post-market activities must be meticulously monitored, documented, and analyzed to ensure ongoing safety and compliance.

Our Post-Market Support Services include:

  • Real-World Product Usage Analysis: Understand how your product is being used in practice to uncover potential issues.
  • Post-Market Surveillance (PMS): Gather and analyze field data to detect emerging risks and trends.
  • Post-Market Clinical Follow-Up (PMCF): Conduct studies to assess long-term safety and performance in real-world scenarios.
  • Regulatory Reporting Assistance (21 CFR Part 803 | MDR): Ensure timely and accurate reporting to the FDA and other regulatory authorities.
  • Recall Management Support: Guide you through the recall process, minimizing business disruption and regulatory risks.

At RQMIS, we don’t just help you react to post-market challenges—we equip you with systems and strategies to proactively monitor, assess, and improve your product in real-world use. With our support, you’ll be prepared to address regulatory requirements, enhance product performance, and most importantly, ensure patient safety and trust remain at the forefront of your operations.