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OFTWARE
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EVELOPMENT
October 2013
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Running functional tests and structural cover-
age analysis makes sure all code paths are exer-
cised and the interfaces between multiple units
verified. It also helps to ensure the system
functions per the design, even with the inte-
gration of the SOUP items. Notably, IEC 62304
requires that verification of the SOUP items
follows the integration plan made during the
software planning, again indicating the elevated
emphasis IEC 62304 places on ensuring up-
grades to medical software do not introduce
errors. RTM provides traceability between the
various analysis performed on SOUP items
against the test plan established earlier.
This test plan contains test cases to be carried
out and their expected results based on the
system requirement. Using RTM, project man-
agers can estimate the impact of SOUP items
to be incorporated and how it affects the safety
of the system. Many incidents in the medical
device industry are related to service or mainte-
nance of medical device systems including in-
appropriate software updates and upgrades.
SOUP items also play a major role here since
these items are delivered by different vendors
and need to be verified. In IEC 62304, the soft-
ware maintenance process is considered as im-
portant as the software development process.
This emphasis on maintenance aims at curbing
the high percentage of medical device software
defects introduced after product release (i.e.
during software maintenance).
The maintenance process requires that the
manufacturer monitor the feedback of the
released product from both within the organ-
ization and from the user. This feedback must
be documented and analyzed to determine
whether a problem exists. When a problem is
found, a problem report is created and
analysed to determine whether SOUP items
contributed for the problem. If SOUP is a
problem, the issue has to be conveyed to the
respective vendor to address the problem
with upgrades or patches.
IEC 62304 requires the manufacturer to estab-
lish procedures to evaluate and implement
upgrades, bug fixes, patches and obsolescence
of SOUP items. Each upgrade, bug fix and
patch has to be analysed and verified to deter-
mine whether additional potential causes are
introduced by these upgrades contributing to
a hazardous situation. As always, it is necessary
to determine whether additional software risk
control measures are required. During main-
tenance, the manufacturer is required to analyse
changes to the SOUP items to determine
whether the software modification could in-
terfere with the existing risk control measures.
The manufacturer must establish a scheme
for the unique identification of configuration
items and their versions. For each SOUP con-
figuration item used, the manufacturer needs
to document the title, SOUP manufacturer
name and unique SOUP designator. This iden-
tification identifies the software configuration
items and the versions included in the medical
device software.
Product News
ARM and Oracle to optimize Java SE
for Embedded markets
ARM has entered into a multi-year agreement
with Oracle to further optimize the existing
Java Platform, Standard Edition (Java SE) for
ARM 32-bit platforms and to add Java SE
support for ARMv8 64-bit platforms. This
agreement will focus on delivering throughput
and efficient scalability for ARM-based multi-
core systems. This agreement reflects the in-
creasing applicability of the combination of
ARM and Oracle technology in server and
TI introduces Tiva C series TM4C123G
USB+CAN Development Kit
New development kit from Texas Instruments
provides compact, versatile evaluation platform
for Tiva C Series TM4C123GMCUs, including
robust software for easy USB and CAN con-
nectivity. The development kit includes every-
thing a designer needs for a full system evalu-
ation – host and device USB cables, on-board
debug interface, and a coin cell battery for
ode.
IAR: ARM tools offering with support for
Renesas’ new RZ MPUs
IAR Systems announces full coverage for the
RZ/A ARM Cortex-A9 microprocessor units
from Renesas. The complete development tool-
chain IAR Embedded Workbench provides
powerful code optimizations and comprehensive
debugger features, including innovative Power
Debugging technology, in a reliable and easy-
to-use integrated development environment
support.
Lauterbach: μTrace all-in-one debug and
trace solution for Cortex-M
In response to the breakthrough of Cortex-M
processors into the embedded market, Lauter-
bach has developed a new all-in-one debug
and trace solution, which will be launched in
August 2013. Lauterbach has extended their
portfolio with a new product called μTrace, de-
e ARMCortex-M family.
Digia: Qt 5.1 with preliminary Android
and iOS support
Digia has announced the release of Qt 5.1 cross-
platform application and user interface devel-
opment framework. Qt 5.1 includes significant
improvements to Qt Quick, the Qt-specific de-
clarative UI language making it easier to develop
graphically-rich UIs quickly and efficiently, it
brings in new APIs, and improves performance
and stability with the implementation of over
the previous version.
SYSGO: PikeOS is on board A350 aircraft
from Airbus
SYSGO announced that their PikeOS safe and
secure virtualization platform has been selected
by Airbus for the FSA-NG (Fly Smart with
Airbus New Generation), a DO178B certified
equipment to be deployed on the A350 XWB
aircraft. The purpose of the FSA-NG system is
to provide the pilot with access to applications
and information during the flight as well as to
tenance team.
LDRA chooses Softline to take LDRA tool
suite to Russia and CIS states
LDRA has chosen Softline to distribute the
LDRA tool suite and LDRA’s Certification
Services to Russia and the Commonwealth of
Independent States. LDRA’s certification man-
agement and software test verification tech-
nologies promise new compliance efficiencies
and process management to Russia’s safety-
critical industries. Together, Softline and LDRA
will target standards-based certification for
aerospace and defense (KT-178B, DO-178B/C,
DO-278), automotive (ISO 26262), rail and
industrial safety (IEC 61508), nuclear (IEC
IEC 62304).
LieberLieber: provides improved
model-based systems engineering
LieberLieber EnArSys is a tool extension for
Sparx Systems Enterprise Architect to improve
the system modeling capabilities using the
Systems Modeling Language. The EnArSys ex-
tension also provides further elements and
connectors to support functional safety man-
agement (FSM, IEC61508, ISO26262) aspects
and the EnArSys modeling methodology. Oliver
Alt as the SysML specialist in the LieberLieber
team wrote a german book in which he de-
scribes the EnArSys modeling methodology
in more detail: Modellbasierte Systementwick-
er Verlag, 2012.
