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:
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.
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.