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Glossary of Terms

DataReality Glossary Header
  • FMEA: Failure Mode and Effects Analysis.
  • CRA: Compliance Risk Assessment.
  • 510(k): US FDA premarket notification route.
  • PSUR: Periodic Safety Update Report.
  • Event: recorded incident associated with a device or product.
  • Malfunction: device issue causing failure of intended operation.
  • Injury: patient injury linked to an event; can be serious or non‑serious.
  • Recalls: regulatory/manufacturer actions affecting products.

Additional Likely Glossary Terms

Regulatory & Standards​

  • 21 CFR Part 820: The FDA’s Quality System Regulation (QSR) for medical device manufacturers.
  • EU MDR: European Union Medical Device Regulation (Regulation (EU) 2017/745).
  • ISO 13485: The international standard for Quality Management Systems for medical devices.
  • IMDRF: International Medical Device Regulators Forum (often creates codes for adverse events).
  • MDSAP: Medical Device Single Audit Program.

Risk & Safety (Post-Market Surveillance)​

  • AE (Adverse Event): Any untoward medical occurrence in a patient or clinical investigation subject administered a product.
  • SAE (Serious Adverse Event): An adverse event that results in death, life-threatening injury, or permanent impairment.
  • PMS (Post-Market Surveillance): The proactive collection and review of experience gained from devices placed on the market.
  • PMCF (Post-Market Clinical Follow-up): A continuous process that updates the clinical evaluation.
  • HHE (Health Hazard Evaluation): An assessment used to determine if a recall is necessary.

Quality Processes​

  • CAPA (Corrective and Preventive Action): A process to identify the root cause of non-conformities and prevent their recurrence.
  • NC (Non-Conformance): Non-fulfillment of a specific requirement (e.g., a product defect).
  • Complaint: Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device.
  • RCA (Root Cause Analysis): The process of discovering the root causes of problems in order to identify appropriate solutions.

Documentation & Identification​

  • DHF (Design History File): A compilation of records that describes the design history of a finished device.
  • DHR (Device History Record): Records containing the production history of a finished device (proof it was made according to the DMR).
  • DMR (Device Master Record): The "recipe" for the device; contains all specifications and procedures for manufacturing.
  • UDI (Unique Device Identification): A unique numeric or alphanumeric code used to identify medical devices within the supply chain.
  • eMDR: Electronic Medical Device Reporting (submitting reports to the FDA digitally).