Risk Management File – CardioMonitor Pro ECG-12¶

In accordance with ISO 14971:2019 – Application of risk management to medical devices¶

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Document Information¶

Document: Risk Management File
Product: CardioMonitor Pro ECG-12
Model Number: CM-ECG-12-2025
Version: 1.1.0
Gültig ab: 17. November 2025- Erstellungsdatum: 17. November 2025- Letzte Überarbeitung: 17. November 2025- Creation Date: 22 September 2025
Letzte Überarbeitung: 19. November 2025- Last Revision: 22 September 2025
Nächste Überprüfung: 19. November 2026- Prepared By: [Risk Manager Name]
Approved By: [Quality Manager Name]

1. Purpose & Scope¶

1.1 Purpose¶

This Risk Management File documents the systematic application of the ISO 14971:2019 risk management process for the CardioMonitor Pro ECG-12. It covers identification, analysis, evaluation, control of risks, and monitoring of the effectiveness of implemented controls.

1.2 Scope¶

Product: 12‑lead electrocardiograph CardioMonitor Pro ECG-12
Intended Use: Non‑invasive acquisition and analysis of cardiac electrical activity
Lifecycle Phases: Development, manufacturing, distribution, use, servicing, disposal
Applicable Standards: ISO 14971:2019, IEC 60601‑1, IEC 60601‑2‑25

1.3 Definitions & Abbreviations¶

Risk: Combination of the probability of occurrence of harm and the severity of that harm
Harm: Physical injury, health impairment, or property/environmental damage
Hazard: Potential source of harm
ALARP: As Low As Reasonably Practicable
PEMS: Post‑market surveillance system

2. Responsibilities¶

2.1 Risk Management Team¶

Role	Name	Responsibilities
Risk Management Lead	[Name]	Overall ownership of process
Clinical Advisor	[Name]	Clinical assessment of risks
Engineering Lead	[Name]	Technical risk evaluation
Quality Manager	[Name]	Oversight & documentation integrity
Regulatory Affairs Manager	[Name]	Regulatory compliance alignment

2.2 Decision Authority¶

Risk Acceptance: Risk Management Lead
Risk Control Selection: Engineering Lead with team consensus
Product Release: Executive Management based on RM report

3. Risk Management Process¶

3.1 Process Overview¶

Aligned with ISO 14971:2019 requirements: 1. Risk Analysis – Intended use definition, hazard identification, foreseeable misuse sequencing
2. Risk Evaluation – Probability, severity, classification
3. Risk Control – Control option selection, implementation, verification, residual risk evaluation
4. Overall Residual Risk Evaluation – Benefit–risk review & acceptability statement

3.2 Risk Acceptability Criteria¶

Risk Matrix¶

Probability	Critical (5)	Serious (4)	Moderate (3)	Minor (2)	Negligible (1)
Very High (5)	25	20	15	10	5
High (4)	20	16	12	8	4
Medium (3)	15	12	9	6	3
Low (2)	10	8	6	4	2
Very Low (1)	5	4	3	2	1

Classification¶

Score 16–25: Unacceptable – immediate action required
Score 9–15: Conditionally acceptable – controls mandatory
Score 4–8: Acceptable – monitor
Score 1–3: Negligible – no further action

4. Risk Analysis¶

4.1 Intended Use & Foreseeable Misuse¶

Intended Use:
- 12‑lead ECG acquisition (adult & pediatric ≥2 years)
- Use by trained medical professionals
- Inpatient & outpatient diagnostics
- Supportive diagnostic aid (not sole basis for critical decisions)

Foreseeable Misuse:
- Untrained operator usage
- Application on patients <2 years without appropriate pediatric electrodes
- Use inside MRI suite
- Continuous monitoring beyond intended session (>30 min)
- Reliance as sole diagnostic source

4.2 Hazard Identification¶

4.2.1 Energy‑Related Hazards¶

Hazard	Description	Potential Causes
Electric shock	Patient contact with conductive fault	Insulation failure, damaged cable
Burns	Overheating of electrodes/device	Component failure, overload
Defibrillation damage	Device harmed by external shock	Use during defibrillation

4.2.2 Biological / Chemical Hazards¶

Hazard	Description	Potential Causes
Cross infection	Pathogen transfer	Inadequate cleaning, contaminated electrodes
Allergic reaction	Skin response to materials	Latex/metal sensitivity
Skin irritation	Redness, abrasion	Prolonged application, friction

4.2.3 Operational Hazards¶

Hazard	Description	Potential Causes
Misdiagnosis	Incorrect ECG interpretation	Software fault, artifacts, user error
Data loss	Loss of patient ECG data	HW/SW failure, improper handling
Delayed diagnosis	Latency in critical result	Device malfunction, insufficient alarm

4.2.4 Information Hazards¶

Hazard	Description	Potential Causes
Wrong patient assignment	Patient data mix-up	User error, software bug
Privacy breach	Unauthorized access	Insecure transmission, cyber attack
Incomplete documentation	Missing ECG records	User error, device fault

5. Risk Evaluation¶

5.1 Detailed Evaluation (Representative Risks)¶

R001 – Electric shock (insulation failure)
- Harm: Arrhythmia, burns, death
- Probability: 2 (Low)
- Severity: 5 (Critical)
- Score: 10
- Classification: Conditionally acceptable

R002 – Misdiagnosis (software fault)
- Harm: Incorrect/delayed treatment, deterioration
- Probability: 3 (Medium)
- Severity: 4 (Serious)
- Score: 12
- Classification: Conditionally acceptable

R003 – Allergic reaction (electrode contact)
- Harm: Local skin inflammation
- Probability: 4 (High)
- Severity: 2 (Minor)
- Score: 8
- Classification: Acceptable

R004 – Cross infection (surface contamination)
- Harm: Secondary infection, possible sepsis
- Probability: 3 (Medium)
- Severity: 4 (Serious)
- Score: 12
- Classification: Conditionally acceptable

R005 – Data loss (hardware failure)
- Harm: Delayed diagnosis, legal impact
- Probability: 2 (Low)
- Severity: 3 (Moderate)
- Score: 6
- Classification: Acceptable

6. Risk Control¶

6.1 Control Measures (Selected Examples)¶

R001 – Electric Shock¶

Priority 1 (Inherently Safe Design): Double insulation (IEC 60601‑1), Class II construction, leakage current <10 µA, surge protection.
Priority 2 (Protective Measures): Automatic isolation self‑test at power‑up, conductive part monitoring, temperature sensors.
Priority 3 (Information for Safety): IFU warnings, periodic safety tests, operator training.

R002 – Misdiagnosis¶

Priority 1: Validated algorithms (>95% sensitivity), redundant parameter computation, automated signal quality checks.
Priority 2: Visual/audible warnings for low confidence analysis, physician confirmation recommendation, storage of raw waveforms.
Priority 3: Detailed IFU interpretation guidance, user training program, analytical disclaimers.

R003 – Allergic Reaction¶

Priority 1: Hypoallergenic materials, latex‑free design, ISO 10993 biocompatibility tests.
Priority 2: Limited application time guidance, alternative electrode options.
Priority 3: Warnings on potential reactions, pre‑use skin assessment instruction.

R004 – Cross Infection¶

Priority 1: Cleanable smooth surfaces, antimicrobial coatings, single‑use electrodes standard.
Priority 2: Automated cleaning reminders, optional UV‑C accessory.
Priority 3: Detailed cleaning/disinfection IFU, infection prevention training.

R005 – Data Loss¶

Priority 1: Redundant storage (local + backup), automatic backup routines, ECC memory.
Priority 2: Battery‑buffered memory, integrity checks, cloud sync option.
Priority 3: Instructions for routine data export, maintenance guidance.

6.2 Verification (Sample Protocols)¶

Electrical Safety Test: Leakage current measurement – Result 8.5 µA (limit 10 µA) ✓
Algorithm Validation: Clinical dataset (n>500) – Sensitivity 96.2%, specificity 98.1% ✓
Biocompatibility: ISO 10993‑10 sensitization – No sensitizing properties ✓

6.3 Residual Risk Evaluation¶

Risk	Original Score	Post‑Control	Status
R001	10	4	Acceptable
R002	12	6	Acceptable
R003	8	4	Acceptable
R004	12	6	Acceptable
R005	6	3	Negligible

7. Overall Residual Risk Acceptability¶

7.1 Benefit–Risk Analysis¶

Medical benefits include: early arrhythmia & ischemia detection, improved patient safety via rapid assessment, reduced diagnostic error risk, cost‑efficient workflow.
Post‑control residual risks are all ≤6; no unacceptable residual risk remains; benefits clearly outweigh remaining risks.

7.2 Acceptability Statement¶

Based on systematic analysis:
1. All identified risks evaluated
2. Appropriate controls implemented
3. Residual risks acceptable
4. Clinical benefit materially exceeds residual risk
5. Overall residual risk deemed acceptable

Release Decision: CardioMonitor Pro ECG-12 cleared for market introduction.

8. Risk Management Report¶

8.1 Summary of Activities¶

Performed:
- [x] Plan established
- [x] Hazard analysis completed
- [x] 25 risks identified/evaluated
- [x] Controls defined & implemented
- [x] Verification executed
- [x] Residual evaluation completed
- [x] Benefit–risk review performed

Results:
- Total risks: 25
- Initially unacceptable: 2
- Remaining unacceptable: 0
- Control measures implemented: 47

8.2 Open Items & Follow‑Up¶

Quarterly post‑market data review
Algorithm improvement releases
Annual control effectiveness reassessment

8.3 Recommendations¶

Deploy proactive PMS system
Maintain structured user training
Continuous algorithm refinement
Annual RMF review

9. Post-Market Surveillance¶

9.1 PMS Plan¶

Data Sources: Complaints, user feedback, service reports, vigilance submissions, literature monitoring.
Parameters: Device failure rate, software/algorithm performance, allergic / skin events, infection transfers, diagnostic incident reports.
Reporting: Quarterly internal reviews; annual PMS report; ad‑hoc escalation for critical events.

9.2 Update Criteria¶

RMF updated if: new risks emerge; frequency shifts significantly; new controls added; regulatory changes occur; design modifications implemented.

9.3 Continuous Improvement¶

Planned measures: predictive risk ML models; preventive maintenance analytics; UI refinements from feedback; cybersecurity hardening enhancements.

10. Annexes¶

Annex A: Full Risk Table¶

[Comprehensive table of all 25 risks – maintained separately]

Annex B: Test Protocols¶

[Verification protocols for each implemented control]

Annex C: References & Standards¶

ISO 14971:2019 – Medical device risk management
IEC 60601‑1:2012 – General safety
IEC 60601‑2‑25:2011 – ECG device particulars
ISO 13485:2016 – QMS
MDR 2017/745 – Regulation

Annex D: Change History¶

Date	Version	Author	Changes
19. November 2025	1.1.0	Unbekannt	Automatische Metadatenaktualisierung
17. November 2025	1.0.1	Unbekannt	Automatische Metadatenaktualisierung

Approvals¶

Role	Name	Signature	Date
Risk Management Lead	[Name]	[Signature]	[Date]
Quality Manager	[Name]	[Signature]	[Date]
Executive Management	[Name]	[Signature]	[Date]

Confidential – Use only for its intended purpose.