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1 A list of damages resulting from a hazard shall be included in the list of hazardous situations

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2 Any new or increased risks shall be managed in accordance with risk analysis, risk evaluation and risk control

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3 Documentation of hazards and hazardous situations shall be maintained in the risk management file

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4 Documentation of intended use shall be maintained in the risk management file

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5 For any damage identified, the manufacturer shall assess and control the risk

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6 For each hazard identified, the manufacturer shall consider events that may result in a hazardous situation

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7 For each hazard identified, the manufacturer shall identify and document the resulting hazardous situations

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8 For each hazardous situation identified, the manufacturer shall determine whether the risk is acceptable or not

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9 For each hazardous situation identified, the manufacturer shall estimate the associated risks

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10 For each hazardous situation identified, the manufacturer shall evaluate the estimated risks

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11 For each medical device, the manufacturer shall create and maintain a risk management file

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12 If a residual risk is judged acceptable using the criteria for risk acceptability defined, further risk control measures shall be considered

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13 If a residual risk is not judged acceptable using the criteria for risk acceptability defined, further risk control measures shall be considered

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14 If the benefits outweigh the residual risk, the manufacturer shall modify the medical device or its intended use

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15 If the collected information is determined to be relevant to safety, the manufacturer shall review the risk management file

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16 If the collected information is determined to be relevant to safety, the manufacturer shall evaluate the impact on previously implemented risk control activities

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17 If the collected information is determined to be relevant to safety and if a residual risk is no longer acceptable, the impact on previously implemented risk control measures shall be evaluated

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18 If the collected information is determined to be relevant to safety, any decisions and actions shall be recorded in the risk management file

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19 If the collected information is determined to be relevant to safety, the manufacturer should consider the need for actions regarding medical devices on the market

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20 If the collected information is determined to be relevant to safety, the results of this evaluation shall be considered as input for the review of the suitability of the risk management process

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21 If the information collected is not considered relevant to safety, the manufacturer shall review the risk management file

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22 If the manufacturer determines that a reduction in risk is achievable, it shall conduct a benefit-risk analysis of the residual risk

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23 If the manufacturer determines that a reduction in risk is not achievable, it shall conduct a benefit-risk analysis of the residual risk

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24 If the overall residual risk is considered acceptable, the manufacturer shall inform users of the significant residual risks

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25 If the overall residual risk is considered acceptable, the manufacturer shall include the necessary information in the accompanying documentation

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26 If the overall residual risk is not considered acceptable, the manufacturer shall inform users of the significant residual risks

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27 If the risk is acceptable, the estimated risk shall be treated as a residual risk

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28 If the risk is acceptable, the manufacturer shall carry out risk control activities

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29 If the risk is not acceptable, the manufacturer shall carry out risk control activities

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30 Individual personnel competency files shall be recorded in the risk management file

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31 Persons performing risk management tasks shall be competent

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32 Prior to marketing the medical device, the manufacturer shall review the execution of the risk management plan

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33 Qualitative and quantitative characteristics likely to affect the safety of the medical device shall be included in the risk management plan

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34 Responsibility for reviewing the implementation of the risk management plan shall be assigned in the risk management plan to persons with appropriate authority

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35 Review of the execution of the risk management plan shall at least ensure that the overall residual risk is acceptable

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36 Risk analysis shall include risk evaluation

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37 Risk management activities shall be planned

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38 Risk management plan shall include management responsibility

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39 The effectiveness of risk control measures shall be verified

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40 The implementation of each risk control measure shall be verified

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41 The manufacturer shall also consider the need to actively collect and review of publicly available information about similar medical devices and other similar other products on the market

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42 The manufacturer shall collect information generated by the supply chain

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43 The manufacturer shall collect information generated by the user

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44 The manufacturer shall collect information generated by those accountable for the installation, use and maintenance of the medical device

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45 The manufacturer shall collect information generated during production and monitoring of the production process

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46 The manufacturer shall collect information related to the generally acknowledged state of the art

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47 The manufacturer shall collect publicly available information

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48 The manufacturer shall collect information from the risk management process

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49 The manufacturer shall consider appropriate methods for the collection and processing of information

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50 The manufacturer shall define the limits of the qualitative and quantitative characteristics likely to affect the safety of the medical device

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51 The manufacturer shall determine risk control measures

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52 The manufacturer shall document any reasonably foreseeable misuse

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53 The manufacturer shall document the intended use of the medical device

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54 The manufacturer shall establish and document a risk management plan

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55 The manufacturer shall establish, document and maintain a process for identifying hazards and hazardous situations associated with a medical device

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56 The manufacturer shall establish, document and maintain a system for actively collect and review information relevant to the medical device in the production and post-production phases

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57 The manufacturer shall evaluate the overall residual risk posed by the medical device, taking into account the contributions of all residual risks, in relation to the benefits for the intended use

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58 The manufacturer shall evaluate the residual risk using the criteria for risk acceptability defined in the risk management plan

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59 The manufacturer shall examine the effects of risk control measures taking into account the economic benefits

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60 The manufacturer shall identify and document known and foreseeable hazards associated with the medical device

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61 The manufacturer shall identify and document those qualitative and quantitative characteristics that could affect the safety of the medical device

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62 The manufacturer shall identify and document those qualitative and quantitative characteristics that could affect the safety of the medical device

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63 The manufacturer shall implement risk control measures following the risk analysis

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64 The manufacturer shall implement the chosen risk control measures

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65 The manufacturer shall perform risk analysis for the particular medical device

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66 The manufacturer shall review risk control activities to ensure that risks arising from all identified hazardous situations have been addressed

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67 The manufacturer shall review risk control activities to ensure that all risk control activities are completed

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68 The manufacturer shall review the effects of the risk control measures with regard to whether new hazards or hazardous situations are introduced

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69 The manufacturer shall review the effects of the risk control measures with regard to whether the estimated risks for previously identified hazardous situations are affected by the introduction of the risk control measures

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70 The manufacturer shall review the information collected for possible relevance to safety, especially whether previously unrecognized hazards or hazardous situations are present

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71 The manufacturer shall review the information collected for possible relevance to safety, especially whether an estimated risk arising from a hazardous situation is no longer acceptable

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72 The manufacturer shall review the information collected for possible relevance to safety, especially whether the overall residual risk is no longer acceptable in relation to the benefits of the intended use

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73 The manufacturer shall review the information collected for possible relevance to safety, especially whether the generally acknowledged state of the art has changed

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74 The manufacturer shall use one or more of the risk control options, such as inherently safe design and manufacture

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75 The manufacturer shall use one or more of the risk control options, such as protective measures in the medical device itself

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76 The manufacturer shall use one or more of the risk control options, such as protective measures in the manufacturing process

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77 The manufacturer shall use one or more of the risk control options, such as information for safety

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78 The manufacturer shall use one or more of the risk control options, such as training to users

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79 The results of risk estimation activities shall be recorded in the risk management file

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80 The results of the benefit-risk analysis shall be recorded in the risk management file

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81 The results of the information review shall be recorded in the risk management file

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82 The results of the information review shall be recorded in the risk management plan

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83 The results of the overall Residual risk evaluation shall be recorded in the risk management file

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84 The results of the Residual risk evaluation shall be recorded in the risk management file

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85 The results of the review of risk control activities shall be recorded in the risk management file

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86 The results of the review of the effects of risk control measures shall be recorded in the risk management file

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87 The results of the review of the execution of the risk management plan shall be recorded and maintained in the form of a risk management report

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88 The results of the review of the execution of the risk management plan shall be included in the risk management file

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89 The results of the risk analysis shall be recorded in the risk management file

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90 The results of the risk analysis shall include identification of the person and organization that carried out the risk analysis

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91 The results of the risk analysis shall include the identification and description of the medical device that was analyzed

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92 The results of the risk analysis shall include the scope

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93 The results of the risk evaluation shall be recorded in the risk management file

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94 The results of verification of the effectiveness of risk control measures shall be recorded in the risk management file

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95 The review of the execution of the risk management plan shall at least ensure that the risk management plan has been implemented appropriately

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96 The review of the execution of the risk management plan shall at least ensure that appropriate methods are in place to collect and review information at the production and post-production stages

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97 The risk control measures selected shall be recorded in the risk management file

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98 The risk management file shall allow traceability for each identified hazard

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99 The risk management file shall include in paper form all records related to the medical device

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100 The risk management plan shall be part of the risk management file

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101 The risk management plan shall include a method to evaluate the overall residual risk

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102 The risk management plan shall include activities related to relevant production and post-production information

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103 The risk management plan shall include criteria for acceptability of overall residual risk

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104 The risk management plan shall include requirements for review of risk management activities

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105 The risk management plan shall include the assignment of responsibilities and authorities

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106 The risk management plan shall include the scope

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107 The risk management process shall apply throughout the life cycle of the medical device

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108 The risk management process shall be available in flow diagram form

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109 The risk management process shall include production and post-production activities

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110 The risk management process shall include risk analysis

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111 The risk management process shall include risk control

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112 The risk management process shall include risk evaluation

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113 The system used for qualitative or quantitative categorization of probability of occurrence of harm and severity of harm shall be recorded in the risk management file

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114 Top management shall define and document a policy to establish risk acceptability criteria

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115 Top management shall ensure that adequate resources are available

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116 Top management shall ensure that competent personnel are assigned for risk management

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117 Top management shall review the adequacy of the risk management process at defined intervals

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Quiz requirements ISO 14971 version 2019

118/119

118 Top management's commitment to risk management shall be recorded in the risk management file

Is it a requirement of the ISO 14971 standard version 2019?

Next question

Quiz requirements ISO 14971 version 2019

119/119

119 Verification of the implementation of each risk control measure shall be recorded in the risk management file

Is it a requirement of the ISO 14971 standard version 2019?

In which clause is this requirement?

In which sub-clause is this requirement?

Next question

Quiz requirements ISO 14971 version 2019