GLGlossary
Risk management.
Identifying the hazards a device could present in use, reducing them, and assessing whether the remaining risk is acceptable.
Following the process in ISO 14971, hazards are identified, measures to reduce them are built into the design, and the residual risk is evaluated and recorded. It is not a one-time exercise at the design stage but a lifecycle activity that keeps being updated with information gathered after the device reaches the market. Risk management documentation may be requested during review, and the level of detail expected can differ with the device's class and characteristics.
Related work & timing
This is prepared alongside the technical documentation as a risk management file (plan, analysis, and report). Because it feeds into the choice of test items, starting early pays off.
Basis
- ISO 14971 (Medical devices — Application of risk management to medical devices)
- Regulation on Approval, Notification and Review of Medical Devices (MFDS notification)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.
Other terms
← Back to glossary- Regulatory approval
- Classification (device class)
- Technical documentation
- KGMP (manufacturing and quality management standard)
- Test report
- Clinical evaluation
- Import and manufacturing business
- Post-market management
- Certification body / review body
- Labeling and advertising
- ISO 13485
- Manufacturer and manufacturing site
- Identical, equivalent, and improved devices
- UDI (Unique Device Identification)
- CB test report
- Validation