Page 239 - Safety Risk Management for Medical Devices

218 Safety Risk Management for Medical Devices

Flow of information from clinical investigations (ISO 14155) to risk management
(ISO 14971):
• Confirmation of benefits
• Confirmation of risk estimates
• Verification of effectiveness of Risk Controls, user interface design, and
Information For Use (IFUs)
• Confirmation of predicted Hazards and discovery of any new Hazards
There are also additional activities that provide information to both clinical investi-
gations and risk management, namely:
• Structured scientific literature reviews to identify any reported known and
potential Hazards, risks, performance issues, benefits, and claims. Literature
reviews include same and similar devices, and also nonsimilar devices that have
similar elements as the subject device.
• Identification and evaluation of alternatives available to patients.
• Review of complaints data.
• Review of Medical Device Regulations.
• Review of public databases, e.g., FDA MAUDE adverse event report database
(United States), and EDUAMED (European).