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03/12/2017 © Lero 2015 1 Regulated Software Research Centre Approach to the Development of a Medical Device Software Quality Assurance Framework
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03/12/2017 © Lero 2015 1
Regulated Software Research Centre
Approach to the Development of a Medical DeviceSoftware Quality Assurance Framework
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Andrzej Beniamin Bujok
Supervised by Dr. Fergal McCaffery,
Dr. Silvana Togneri MacMahon, Dr. Peadar Grant
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Overview
Research Motivation
Research Problem
Research Approach – Development of a Medical Device SQA Framework
Research Questions
Research Progress to Date
Future Research
Conclusions
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Research Motivation Malfunctioning medical devices
can cause serious injury or death of patients
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Research Motivation
Adherence to regulations is required and thus there is need to be compliant with international standards to obtain CE mark
Despite certification there is increasing evidence of medical device recalls and adverse events due to software issues
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Research Problem
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with increased
Generic Software System
results innot detected
can cause
increase occurrence of
Software Failure
Resulting in Recalls
Complexity of Software
System along with Evolving
Life Cycle Processes
Software Failure
Resulting in Risk of Injury or Loss of Life
compared to
Insufficient Evolution of
SQA
has to comply with
Medical Device
Software System
to comply with
result in not detected
Unidentified SQA Require-
ments
to prevent
Regulations and Safety Require-
ments
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Research Approach – Development of a Medical Device SQA Framework
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Validation
Verification
Testing
*Vogel, D.A., 2010. Medical Device Software Verification, Validation, and Compliance. Artech House.
Ensuring the product meets specifications
Ensuring the product meets customers expectations
Verification and Validation integrated into Framework
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Research Approach – Development of a Medical Device SQA Framework
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Generic software testing and quality
standards from ISO/TC 210
Medical device software
development standards from
ISO/IEC JTC 1/SC7
Provide requirements
Provide requirements
ISO/IEC 29119:2013 Software Testing Part
1: Concepts and Definitions
ISO/IEC 29119:2013 Software Testing Part
2: Test processes
ISO/IEC 33063:2015 Process Assessment Model for Software
Testing
ISO 25000:2014 Systems and Software Quality
Requirements and Evaluation
ISO 25051:2014 Requirements for quality of Ready to Use Software Product and Instructions
for Testing
IEC 62304:2006 Medical device
software life-cycle processes
IEC/TR 80002-3:2014 Process reference model of medical
device software life-cycle processes
ISO 14971:2012 Application of risk
management to medical devices
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Research Questions
Overall research question:
“How can the development of a medical device software quality assurance framework assist software testing organisations in implementing medical device software verification, validation and testing best practices?”
Sub-questions:
1. “What are the challenges associated with generic and medical device software quality assurance?”
2. “Which international standards and which of their requirements should be taken into account for the development of a medical device software quality assurance framework?”
3. “To what degree does a medical device software quality assurance framework address the challenges in implementing verification, validation and testing best practices?”
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Research Progress to Date – SQ1
„What are the challenges associated with generic and medical deviceSQA?”
Increasing extension and complexity of software systems increases the complexity of software testing including testing of interfaces, integration and documentation
From the software life-cycle processes perspective, testing is no longer performed only during the software implementation but also during the software requirements and design phases
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Research Progress to Date – SQ2
“Which international standards and which of theirrequirements should be taken into account for thedevelopment of a medical device software qualityassurance framework?”
ISO/IEC/IEEE 29119 - Software and systems engineering – Software testing – Family of standards
– Part 1: Concepts and definitions
– Part 2: Test processes
– Part 3: Test documentation
– Part 4: Test techniques
ISO/IEC 33063: 2015 - Information technology -- Process assessment -- Process assessment model for software testing
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Research Progress to Date – SQ2
According ISO/IEC/IEEE 29119, testing is founded on the regulatory situation that an organization is in
Medical device SQA framework – multi-layered test context diagram from ISO/IEC/IEEE 29119-1
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Sample Mapping of ISO/IEC 33063 and IEC/TR 80002-3
High level mapping to examine how the software testing processes can be used in conjunction with software development processes
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Section Process ID Process Name Process Purpose Section Process Name Process Purpose
5.2 PG Organisational Test
Process Group
5.2.1 OT.1 Organisational Test
Process
The Purpose of the
organisational test process
is to develop, monitor
conformance and maintain
organisational test
specifications, such as the
organisational test policy
and organisational test
strategy.
4.1.1 Software
development
Planning
The purpose of software
development planning (IEC
62304, 5.1) is to establish a
plan for conducting the
activities of the software
development processes.
Annex E
E1.1
OT.2 Skill Development
Training Process
(Additional Process)
The purpose of the training
process is to provide the
organisation and project
with individuals who
possess the needed skills
and knowledge to perform
their roles effectively.
ISO/IEC 33063: 2015 (PAM) PD IEC/TR 80002-3:2014 (PRM)
The processes related to each other are introduced in the same line. The results of the mapping indicate the potential for detailed mapping and integration.
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Mapping of IEC 62304 and ISO/IEC/IEEE 29119-2
IEC 62304 does imply dependencies between processes – inputs of a process are generated by another process. Another mapping to examine the dependencies between the processes of ISO/IEC/IEEE 29119-2 and IEC 62304 in terms of input and output.
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The results of both mappings demonstrate a potential for integration their requirements into the framework
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Future Research
Development of the medical device SQA framework
– The review of literature and standards to be continued
– Low level mapping of IEC 62304 (IEC/TR 80002-3) and ISO/IEC/IEEE 29119-2 (ISO/IEC 33063)
– Mapping of other relevant standards to ISO/IEC/IEEE 29119-2
– Integration of relevant requirements into the medical device SQA framework
Validation of the medical device SQA framework
– Validation of the framework by experts from standards community
– Validation of the framework by software development organisation
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Conclusions
The adverse events and rising recalls of medical devices due to software issues demonstrate the need for improvement of medical device SQA.
Standards related to generic and medical device software testing and quality can address identified SQA challenges.
There is no single standard that incorporates requirements addressing all identified SQA challenges.
The research approach is to identify relevant standards requirements and integrate them into a medical device SQA framework.
The purpose of the development of a medical device SQA framework is to improve medical device software quality, and possibly increase safety of patients and reduce recalls of medical devices with related costs.
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[email protected]: Andrzej Bujok
This research is supported by Lero - the Irish Software Engineering Research Centre (http://www.lero.ie) grant 10/CE/I1855 and grant
13/RC/20194.
