Page 47 - Safety Risk Management for Medical Devices

26 Safety Risk Management for Medical Devices

• Identify the intended use of the medical device
• Identify the safety characteristics of the medical device
• Identify the Hazards that the device could present
• Estimate the risk for each Hazard
You are required to identify the persons who perform the risk analysis. This is
necessary for confirmation of qualification of such individuals. Also, the date of the
analysis must be recorded.

6.1.1.1 Hazard identification
The Standard [3,7] requires documentation of both known, and foreseeable Hazards
associated with the medical device under both normal and fault conditions. This
creates four types of Hazards. Table 6.1 captures this Hazard taxonomy.
A number of techniques are used to identify the System Hazards. For example,
Fault Tree Analysis (see Section 12.1 for details), and Failure Modes and Effects
Analysis (see Section 12.4 for details).
Other techniques of Hazard identification are: search of published literature for
reported Hazards of similar devices; search of databases such as MAUDE [16], and
EUDAMED [17]; and examination of ISO 14971 [3,7] Annex E, Table E.1.
In Table E.1, there is a listing of many common Hazards that could help with the
identification of Hazards that are related to your medical device.

Table 6.1 Hazard taxonomy
Hazard Type
Known Foreseeable
Normal X X
Fault Condition
Fault X X

6.1.1.2 Risk estimation
Risk estimation methods are explained in detail in Chapter 17, Risk Estimation.

6.1.2 Risk evaluation
Risk evaluation requires knowledge of risk acceptance criteria. See Chapter 19, Risk
Evaluation, for a detailed discussion of risk evaluation.

6.1.3 Risk controls

See Chapter 18 for a detailed discussion of Risk Controls.