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Risk Management and IEC 62304
Applying IEC 62304 Risk Management in Aligned Elements
February 2015
Elements
Medical Devices and Risk Management
Workflows and functions drives
Risk Management
Risk Management drives Design
Design and Risk Management
are interdependent
Traceability connects Design and
Risk Management
Workflows &
Functions
Hazardous Situation
Risk Risk
Control
Design
Elements
Risk Management and Regulations
ISO 13485 QMS
ISO 14971 Risk
Management
IEC 62304 Software Lifecycle
IEC 60601-1 Security in
Electromedical devices
IEC 62366 Usability
Refers to
Refers to
Refers to
Elements
Risk Management and Regulations
ISO 13485 QMS
ISO 14971 Risk
Management
IEC 62304 Software Lifecycle
Design & Maintenance of software in MD
IEC 60601-1 Security in
Electromedical devices
IEC 62366 Usability
Affects
Affects
Affects
Elements
General Concepts of Risk Assessments
Identify Hazards
Evaluate Risks (likelihood & consequences)
Perform Risk Reduction
Evaluate residual Risks
Elements
Risk Management in IEC 62304
Risk drives the level of documentation required
Software Safety Classification of architectural artifacts
Risk inheritance in architecture
Systematic risks => 100% probability of occurrence
Affects not only development, also affects maintenance
Software System
Class C
Software Item
Class C
Software Unit
Class C
Software Unit
Class B
Software Item
Class A
Software Item Class A
Elements
Documenting Medical Device Development
Increasing number of regulations
Development documentation is difficult,
complex and resource intensive to manage
Aligned Elements helps you “build” a
consistent and complete documentation
Free up valuable resources from
cumbersome administrative tasks
Elements
Aligned Elements – a medical device ALM
Manages the DHF Design Control Items
Version Control + Traceability + Documents
Integrated Risk Management
Real-time quality checks on content
Ensures completeness and consistency
Elements
FMEA
Concerns Safety & “Business”
Widely adopted technique
Versatile usage
Probability x Severity x
Visibility
Preliminary Hazard Analysis
Concerns Safety / Harm only
In the early design phase
Full device implementation is
not required
Aligned with ISO 14971
Risk Assessments in Aligned Elements
Elements
Preliminary Hazard Analysis (PHA) Overview
Cause (with probability)
Harm (with severity)
Hazardous Situation
Risk Control Measure
Hazard
Elements
Risk Analysis Element
PHA in Aligned Elements
Cause Harm
(with severity)
Hazardous Situation
Risk Control Measure
Reusable Elements
Probability of Harm
Potential Hazard
Elements
PHA in Aligned Elements
Elements
Aligned Elements PHA in Word
Elements
Risk Analysis
PHA and Traceability
Cause 1
Measure 1 Cause 2
Cause 3 Measure 2
Measure 3
SW Use Case
HW Function
SW Item
SW Requirement
Instructions For Use
HW Specification
Potential Hazards
Elements
Aligned Elements as Risk Management Tool
Automatic calculation of RPN
Automatic checks of RPN against thresholds
Reuse of Harms, Causes and Measures
Measures grouped and sorted according to Risk Reduction Type
Highlighting of insufficiently controlled risks
Highlighting of unimplemented Measures
Risk elements integrated with Design trace landscape
Elements
Risk Management in IEC 62304
Cause
Hazardous Situation
Risk Reduction Measure
Hazard Software Item
Software Requirement
Verification
IEC 62304 – 7.3.3 Document Traceability
Elements
Risk Analysis
IEC 62304 PHA in Aligned Elements
Cause
Measure
Software Item (with classification)
SW Requirement
Verification
Harm Does classification
match Harms in the
Risk Analysis?
Hazardous Situation
Are Risk Control
Measures implemented
and verified?
Elements
Software Safety Classification (SSC) in Aligned
Automatic Rule Checks:
Is SSC consistent with severity of
(implicitly) linked Harms?
Is SSC consistent with classification
of dependent Software Items?
Specify Rules:
SSC inheritance of Software Items
Software Item must trace to Cause
Connect Severity of Harm with SSC
Severity of Harm Classification
5 or 4 C
3 or 2 B
1 A
Elements
Risk Analysis
SSC example in Aligned Elements
Cause
Software Item (Class B)
SW Unit (Class C)
Harm Severity: 5
Not OK!
Not OK!
Severity of Harm Classification
5 or 4 C
3 or 2 B
1 A
Elements
IEC 62304 and Probability in Risk Management
Software error probability is difficult to estimate
Software errors are systematic
IEC 62304 claims that Software Safety Classification shall not depend on probability, only on harm
Assume Probability of software error = 100% (section 4.3. a)
Can we reduce the probability with our Risk Control Measures?
Elements
Use two probabilities:
Probability of Hazardous Situation (P1)
Probability of Harm (P2)
Usage:
P2 can be estimated by professional (e.g.
a Medical Doctor)
Adapt risk policy and thresholds
Risk Control Measures affect P1 and P2
Using two probabilities
Software Error
Hazardous Situation
Harm
P1
P2
Elements
Two probabilities in Aligned Elements
Elements
Two probabilities in Aligned Elements
Elements
Architecture vs. Functional Usage
Architecture: Hierarchical decomposition of Software into Items and Units
Software risk emanates from how we use the software i.e. in which functional context we use the software items
Functional use cuts across the architecture
Use Case 1
(high risk)
Use Case 2
(mid risk)
Use Case 3
(low risk)
SW Item 1
SW Item 2
SW Item 4
SW Item 3
SW Unit 1
SW Unit 2
SW Unit 3
Elements
The Matrix Model in IEC 62304
Elements
Matrix Model in Aligned Elements
Write Use Cases from SW Reqs
Perform Risk Analysis on Use Cases
Generate Causes from Use Cases where applicable
Create Architecture
Map Use Cases to Software Items by connecting Software Items to existing Causes
If applicable, generate new Causes from Software Items and map back to User Cases
Risk Analysis
Causes
Software Requirements
Harm
Hazardous Situation
Software Items
Elements
Software Problem Resolution Process
Record Problem Report
Identify Causes and perform risk analysis
Evaluate Risk
Create Change Request (if applicable)
Verify Change
Risk Analysis Cause
Measure
Problem Report
Change Request
Verification
Harm Hazardous Situation
Elements
Aligned Elements IEC 62304 Package
Full template set for all IEC 62304 Artifacts
Includes clear references to applicable sections in IEC 62304
Full usage of Aligned Elements automatic consistency checks
Integrated Checklists and Review Generators
Preconfigured Word reports
Preconfigured Trace Tables
Preconfigured Queries
Elements
Maximal results, minimal effort
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