MedTech Terms
    The authoritative reference
    All pathsPMS · QA · RA · 9 terms

    Post-Market Mastery

    Surveillance, vigilance, recalls, and the feedback loop into risk and design.

    1. 1
      Post-Market

      Post-Market Surveillance(PMS)

      Activities to monitor device safety and performance after market release.
    2. 2
      Post-Market

      Periodic Safety Update Report(PSUR)

      Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
    3. 3
      Post-Market

      Medical Device Vigilance

      Reporting and management of serious incidents and field safety corrective actions.
    4. 4
      Post-Market

      Field Safety Corrective Action(FSCA)

      Action taken to reduce a risk of serious deterioration in health associated with a device.
    5. 5
      Post-Market

      Medical Device Recall

      Removal or correction of a marketed device that violates FDA law.
    6. 6
      Post-Market

      Medical Device Reporting (FDA)(MDR)

      FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
    7. 7
      Quality & Risk

      Complaint Handling

      Process for receiving, evaluating, and responding to device complaints.
    8. 8
      Quality & Risk

      Corrective and Preventive Action(CAPA)

      Systematic process to investigate and resolve quality issues and prevent recurrence.
    9. 9
      Clinical & Trials

      Real-World Evidence(RWE)

      Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.

    Finished the path? Test yourself with the acronym quiz.