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Risk Analysis Form

Risk management template

Risk Analysis Form for ISO 14971 medical device risk management

Use this editable Risk Analysis to identify hazards, estimate risks, define controls and document that residual risks are acceptable across the full device lifecycle.

Structure ISO 14971 workflowsMap hazards, hazardous situations, harms and risk controls.
Quantify residual riskRate severity and likelihood to support RPN-based decisions.
Link risk to clinical evidenceConnect risk acceptability to state of the art and clinical data.

  • Best for: risk management files, ISO 14971 compliance, hazard analysis and risk control verification.
  • Includes: editable sections for risk analysis, risk evaluation, control measures and residual-risk conclusions.
  • Format: editable template available through the standard WooCommerce download flow.
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Lexqara integrates risk management with clinical evaluation and post-market surveillance so manufacturers can defend risk acceptability to notified bodies. Explore the Resource Center or review our Medical Device Regulatory Training.

Description:
This Risk Analysis Report supports structured FMEA-based risk analysis by documenting hazards, estimating risk, defining controls, and confirming residual risk acceptability across the device lifecycle.

  • Identify Hazards, Hazardous situations, and related Harms with traceable sources.

  • Define the sequence of events and operating condition (normal or fault) for each scenario.

  • Rate Severity and Likelihood to calculate Risk Priority Number (RPN).

  • Classify risk acceptability (e.g., acceptable/undesirable/intolerable) per the defined criteria.

  • Document Risk control measures implemented AFAP and link objective evidence.

  • Record Verification of effectiveness (test/V&V/validation/clinical data) for controls.

  • Re-estimate Residual risk after controls and confirm acceptability.

Your needs:

  • Risk analysis report

  • Risk analysis report for ISO 14971, ISO 13485 and MDR compliance

  • Reduce rework, strengthen traceability, and improve audit readiness.

This spreadsheet is used when performing and updating the device risk analysis to keep risk decisions consistent, reviewable, and evidence-based.

It captures core risk logic. A Hazardous situation is the circumstance where people are exposed to a hazard; it matters because it anchors harms and controls. RPN combines severity and likelihood; it matters because it supports consistent prioritization.

  • Document hazard-to-harm traceability for each scenario.

  • Apply defined severity/likelihood scales and calculate RPN.

  • Record initial risk evaluation and acceptability decision.

  • Define risk controls and link supporting evidence.

  • Verify control effectiveness and record results.

  • Recalculate residual risk and confirm acceptability.

At Lexqara, we align your risk analysis with your risk management plan, design outputs, verification evidence, and technical documentation—supporting regulatory strategy, design support, and audit readiness. Resource Center [https://lexqara.com/resource-center] and Regulatory Strategy [https://lexqara.com/services/regulatory-strategy]. ISO 14971 [https://www.iso.org/standard/72704.html]. Download the template or request a short gap assessment.

Template preview

Template preview: Risk Analysis

Review the key sections included in the Risk Analysis template before downloading it. This preview shows the structure and content you will receive in the editable file.

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Sheet: Generalities

RISK ANALYSIS According to
EN ISO 14971:2019

[Device short Name]

 Document number:
RAZZZZ-XXX
Version : 1
Form number: FORM-DES-013 rev.1
I / Generality
Revision Status
Indice Date Revision History
1 Risk Analysis initiation
Approval
Function Name Date Signature
Product Reference
Device Name: [Device Name] (hereafter named [Device short name])
Model Description
Intended Use & Identification of Characteristics relative to the safety
The intended use and the identification of characteristics relative to the safety is outlined in the Risk Management Plan RMPZZZZ-XXX rev.Y section 5.
II / Risk Management File
The Risk Analysis is part of the Risk Management File: RMFZZZZ-XXX rev.Y.
The Risk Analysis is conducted according to the Risk Management Plan: RMPZZZZ-XXX rev.Y throughout the lifecycle of the device.
A Risk Management Report RMRZZZZ-XXX rev.Y will conclude on the Overall Residual Risk, Overall Balance Benefit / Risk.
III / Summary of clinical Benefit
Every individual residual risk is evaluated against the overall benefits of using [Device Short Name]. To facilitate the benefit-risk (B/R) analysis of individual risks documented in Section IV of this document, the benefits of using [Device Short Name] are described as follows:
Describe the benefits of using the device according to the clinical evaluation report
IV / Risk Analysis

Sheet: FMEA

RISK ANALYSIS According to
EN ISO 14971:2019

[Device short name]

 Document number: RAZZZZ-XXX
Version : 1
Form number: FORM-DES-013 rev.1
ITEMS SOURCE POTENTIAL FAILURE MODE / HAZARD LIFECYCLE NORMAL / FAULT CONDITION POTENTIAL CAUSE(S) OF FAILURE / HAZARDOUD SITUATION(s) POTENTIAL HARM RISK ESTIMATION RISK CONTROL MEASURES VERIFICATION ACTIVITIES RISK ESTIMATION NEW RISK? BALANCE BENEFIT / RISK
S O RPN S O RPN
1 e.g., #A; #3 “Hazard” e.g., Design e.g., Normal “Hazardous situation” “Patient/user harm” 2 3 6 e.g., RCM1 : “echnical specification for component X e.g., V1: cytoxicity test report 2 2 4 e.g., No e.g., Considering the benefits described in Section III, the residual risk is considered acceptable as XXXX. 1
2 0 0 1
3 0 0 1
4 0 0 1
5 0 0 1
6 0 0 1
7 0 0 1
8 0 0 1
9 0 0 1
10 0 0 1
11 0 0 1
12 0 0 1
13 0 0 1
14 0 0 1
15 0 0 1
16 0 0 1
17 0 0 1
18 0 0 1
19 0 0 1
20 0 0 1
21 0 0 1
22 0 0 1
23 0 0 1
24 0 0 1
25 0 0 1
26 0 0 1
27 0 0 1
28 0 0 1
29 0 0 1
30 0 0 1
31 0 0 1
32 0 0 1
33 0 0 1
34 0 0 1
35 0 0 1
36 0 0 1
37 0 0 1
38 0 0 1
39 0 0 1
40 0 0 1
41 0 0 1
42 0 0 1
43 0 0 1
44 0 0 1
45 0 0 1
46 0 0 1
47 0 0 1
48 0 0 1
49 0 0 1
50 0 0 1
51 0 0 1
52 0 0 1
53 0 0 1
54 0 0 1
55 0 0 1
56 0 0 1
57 0 0 1
58 0 0 1
59 0 0 1
60 0 0 1
61 0 0 1
62 0 0 1
63 0 0 1
64 0 0 1
65 0 0 1
66 0 0 1
67 0 0 1
68 0 0 1
69 0 0 1
70 0 0 1
71 0 0 1
72 0 0 1
73 0 0 1
74 0 0 1
75 0 0 1
76 0 0 1
77 0 0 1
78 0 0 1
79 0 0 1
80 0 0 1
81 0 0 1
82 0 0 1
83 0 0 1
84 0 0 1
85 0 0 1
86 0 0 1
87 0 0 1
88 0 0 1
89 0 0 1
90 0 0 1
91 0 0 1
92 0 0 1
93 0 0 1
94 0 0 1
95 0 0 1
96 0 0 1
97 0 0 1
98 0 0 1
99 0 0 1
100 0 0 1
101 0 0 1
102 0 0 1
103 0 0 1
104 0 0 1
105 0 0 1
106 0 0 1
107 0 0 1
108 0 0 1
109 0 0 1
110 0 0 1
111 0 0 1
112 0 0 1
incremental number for the sum of risks (see table below)
This table is not is not printed in the final risk analysis report but is used for the risk management report
Residual risks
RPN Before TOTAL After TOTAL
Level 1 1 0 0 0 1
2 0 0
3 0 0
4 0 1
Level 2 5 0 1 0 0
6 1 0
7 0 0
Level 3 8 0 0 0 0
9 0 0
10 0 0
11 0 0
12 0 0
13 0 0
14 0 0
15 0 0
16 0 0
TOTAL 1 1 1 1
The level and formula needs to be reviewed according to the risk acceptability policy

Sheet: Traceability

RISK ANALYSIS According to
EN ISO 14971:2019

[Device short name]

 Document number: RAZZZZ-XXX
Revsion: 1
Form number: FORM-DES-013 rev.1
Item RISK CONTROL MEASURES TRACEABILITY TO RISK CONTROL MEASURES IMPLEMENTED Item VERIFICATION ACTIVITIES TRACEABILITY TO VERIFICATION ACTIVITIES IMPLEMENTED
RCM1 Technical specification for component X XXXX rev.1 V1 cytoxicity test report YYYY rev.1
RCM2 V2
RCM3 V3
RCM4 V4
RCM5 V5
RCM6 V6
RCM7 V7
RCM8 V8
RCM9 V9
RCM10 V10
RCM11 V11
RCM12 V12
RCM13 V13
RCM14 V14
RCM15 V15
RCM16 V16
RCM17 V17
RCM18 V18
RCM19 V19
RCM20 V20
RCM21 V21
RCM22 V22
RCM23 V23
RCM24 V24
RCM25 V25
RCM26 V26
RCM27 V27
RCM28 V28
RCM29 V29
RCM30 V30
RCM31 V31
RCM32 V32
RCM33 V33
RCM34 V34
RCM35 V35
RCM36 V36
RCM37 V37
RCM38 V38
RCM39 V39
RCM40 V40
RCM41 V41
RCM42 V42
RCM43 V43
RCM44 V44
RCM45 V45
RCM46 V46
RCM47 V47
RCM48 V48
RCM49 V49
RCM50 V50
RCM51 V51
RCM52 V52
RCM53 V53
RCM54 V54
RCM55 V55
RCM56 V56
RCM57 V57
RCM58 V58
RCM59 V59
RCM60 V60
RCM61 V61
RCM62 V62

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