IEC/EN 62304 Medical Device - Software Life Cycle Processes
The standard EN 62304:2006 defines requirements for the life cycle of the development of medical software and for software within medical devices. It applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device.
As EN 62304:2006 does not cover validation and final release of the medical device, is not sufficient to demonstrate compliance with the essential requirements of directives 90/385/EEC and 93/42/EEC. According to this directives, the software must be validated according the "state of the art".
Based on the potential to create a hazard that could result in an injury, the manufacturer has to assign a safety class
to the software system as a whole:
- Safety Class A:
No injury or damage to health is possible.
- Safety Class B:
Non serious injury is possible.
- Safety Class C:
Death or serious injury is possible.
The effort for the development of medical devices depends on these security classes. It is obvious that effort and cost is much higher for the development assigned to class C then for class B or class A.
Software Development Process
Section 5 of IEC/EN 62304 describes the software development process as follows:
1 development planning
2 requirements analysis
3 architectural design
4 detailed design
5 unit implementation and verification
6 integration and integration testing
7 system testing
Software Maintenance Process
The software maintenance process is decribed in section 6 of IEC/EN 62304 as follows:
1 Establish software maintenance plan
2 Problem and modification analysis
3 Implementation of modifications
Software Risk Management Process
Section 7 of the standard ISO/EN 62304 describes the software risk management process as follows:
1 Analysis of software contributing to hazardous situations
2 Risk control measures
3 Verification of risk control measures
4 Risk management of software changes
Techniques and Methods
Regarding the techniques and methods of verification no specific requirements can be derived from the current standard EN 62304.
However there is a growing importance of techniques like static code analysis and test coverage. The usage of professional tools for requiremnents engineering, code analysis and software testing is highly recommanded in order to increase quality and productivity of the software development and to cut costs.
Compliance to IEC/EN 62304 with Tools of Verifysoft Technology
Verifysoft Technology offers proven tools for testing and analysis of software in order to support development teams to fulfill the requirements of IEC/EN 62304:
(for C, C++, Java and C#)
Static Code Analysis:
(for C, C++ and Java)
FDA Uses CodeSecure to Analyze Recalled Medical Devices
Boston Scientific Streamlines Analysis of Medical Device Software
CodeSonar Helps Harvard Apparatus Tackle the Medical Device Market
Compliance with FDA Standards
Code Complexity Measurement Tool for C and C++
Code Complexity Measurement Tool for Java
Certificate / Qualification Kit
For Testwell CTC++ 10.x we provide a Certificate of TÜV Süd Rail GmbH
for the usage of Testwell CTC++ in safety critical projects (all SIL- and ASIL-levels of the supported standards).
Verifysoft offers Qualification Kit for Testwell CTC++
(currently up to version 9.x) which provides documentation, test cases,
and procedures that let you qualify Testwell CTC++ Test Coverage Analyser for projects based on the safety standards ISO 26262, IEC 61508, EN-50128, and DO-178C.