Page 231 - Safety Risk Management for Medical Devices

210 Safety Risk Management for Medical Devices

3. Establish and maintain a risk management file per clause 3.5 of the Standard [3,7].
4. Identify the following for the Legacy Device:
a. Intended use and clinical indication
b. Intended patient population
c. Intended user profile
d. Intended use condition and environment
e. Operating principle
f. Characteristics related to safety
5. Considering item #4 above, identify the Hazards, Hazardous Situations, and
potential Harms from the legacy device.
6. Identify the Risk Control measures that are already in place in the Legacy
Device, and classify them as: Safe by Design, Protective Measures, or
Information for Safety.
7. Create a traceability report among the Hazards, Hazardous Situations, Harms,
and Risk Controls.
8. Create a risk management report to document the above activities.
9. If advances in technology and practices enable the manufacturer to feasibly fur-
ther reduce the device risks, then in the future releases of the legacy device
additional Risk Controls should be implemented and the risk management file
updated, including a new benefit risk analysis.