Risk Management Report

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1. AUDIT TRAIL
Version Change Description Change Date
A Initial version

2. SIGNATURES
Signature Meaning Name Title Date Signature
Author
Reviewed By
Approved By

3. PURPOSE
Document results of risk activities according to the Risk Management Plan (DOC-16 Risk Management
Plan)

4. SCOPE
Activities performed for the new version of the Medical Device

5. REFERENCES AND APPLICABLE DOCUMENTS

DOC-16 Risk Management Plan

6. DEFINITIONS
FMEA : Failure Mode and Effect Analysis

All dates and times are in the project’s default time zone and formatting.
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7. RESPONSIBILITIES
Name Responsability Role
Risk Management Team QA Engineer
Risk Management Team QA/RA Manager

8. REPORT
All features and Requirements have been analyzed to make sure all relevant risks are listed with their
mitigation.

9. RISKS LIST
RISK-1 The device can't be used to read Author: Date: Revision:
notification matrixadmin 2021/05/05 1
15:16:15
Risks / The device can't be used to read notification
Downlinks:
• SREQ-4 The device shall have a USB connector

Hazard Probability of 4 - Often

Occurrence
No power to read physician's
notifications
Sequence of Events

The device was used a lot

The user didn't pay attention to alerts
Hazardous Situation Probability of Harm 2 - Probable

Discharging too quickly due to heavy

usage
Harm Severity 3 - Serious

Don't do the right thing

Risk Before Mitigation (Probability of Occurrence * Probability of 4 * 2 * 3 = 24
Harm * Severity)

Mitigation reduces exposure to hazardous

SREQ-4 The device shall have a USB connector situation by 3

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Risk After Mitigation (Probability of Occurrence * Probability of 1*2*3=6

Harm * Severity)

✔ Cannot be reduced any further

✔ Benefits outweigh remaining risk
Justification / Comments

With USB connector, can easily be charged anywhere

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10. RISK ANALYSIS

10.1. RISK TABLE

Before risk controls After risk controls
Item Hazard Sequen Hazardou Har Probabilit Probabil Severi RB Risk Probabilit Probabil Severi RA
ce of s m y of ity of ty M Controls y of ity of ty M
Events Situation Occurren Harm Occurren Harm
ce ce
RISK-1 No power The Dischargi Don 4 2 3 4* SREQ-4 1 2 3 1*
The to read device ng too 't do 2* The 2*
device physician' was quickly the 3= device 3=
can't be s used a due to right 24 shall 6
used to notificatio lot heavy thin have a
read ns The usage g USB
notificati user connect
on didn't or
pay
attentio
n to
alerts

10.2. RISK LEVELS BEFORE CONTROLS

Summary - Risk levels before controls

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100.0%

Zone 1 Zone 2 Zone 3

• 0 risks in zone 1 - no need for mitigations

• 0 risks in zone 2 - need for mitigation or justification
• 1 risks in zone 3 - need for mitigation

10.3. RISK LEVELS AFTER CONTROLS

Summary - Risk levels after controls

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100.0%

Zone 1 Zone 2 Zone 3

• 1 risks in zone 1 - no need for mitigations

• 0 risks in zone 2 - need for mitigation or justification
• 0 risks in zone 3 - need for mitigation

10.4. TEST COVERAGE OVERVIEW

Summary - Test coverage overview

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1.1

0.9

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0
0

total number of risks risks with mitigations without test cases mitigations without test cases

• 1 total number of risks

• 0 risks with mitigations without test cases
• 0 mitigations without test cases

10.5. RISKS WHICH NEED TO BE FURTHER REDUCED

There are no risks which can be reduced any further!

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10.6. RISKS WHICH ARE NOT JUSTIFIED BY BENEFITS

All remaining risks do not outweigh the benefits of the device.

10.7. RISKS BY ZONE BEFORE CONTROL

risks in zone 1 - no need for mitigations
risks in zone 2 - need for mitigation or justification
risks in zone 3 - need for mitigation
• RISK-1 The device can't be used to read notification

10.8. RISKS BY ZONE AFTER CONTROL

risks in zone 1 - no need for mitigations
• RISK-1 The device can't be used to read notification
risks in zone 2 - need for mitigation or justification
risks in zone 3 - need for mitigation

10.9. RISKS WITHOUT TESTS

If risks have mitigations, these mitigations are covered by test cases

10.10. RISK CONTROLS WITHOUT TESTS

All mitigations are covered by test cases

All dates and times are in the project’s default time zone and formatting.
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10.11. TRACES FROM RISKS TO TESTS

• RISK-1 The device can't be used to read notification
• SREQ-4 The device shall have a USB connector
• VER-2 Notifications test

All dates and times are in the project’s default time zone and formatting.
 Risk Management Report
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11. OVERALL RISK/BENEFIT ANALYSIS AND CONCLUSION

All risks have been reduced as far as possible. The remaining overall risks are considered to be
acceptable.
The benefits of the medical device are considered to outweigh the remaining risk level.

All dates and times are in the project’s default time zone and formatting.