Automated Testing | 33
industries including medical device code in such a way that it will satisfy
manufacturing. Rules dictated by the design requirements. Both of
The European Parliament and the those considerations need to happen,
Medicines and healthcare products but developers now need to ask
Regulatory Agency (MHRA) are themselves: “Am I writing this software
having an increasingly important role in a way that is making my code or
to play in the production of medical the whole system less reliable?” The
devices in the UK and Europe. In the reality is most developers probably
United States, the Food and Drug can’t answer that question. Many
Administration (FDA) published a well programming bugs can often seem
known guideline: General Principles of quite innocuous to the untrained
Software Validation, which outlines eye, so it’s critical that developers are
recommended best practices for not only provided with the proper
virtually all aspects of software tools to write code without serious
development. bugs, but they have the knowledge to
While regulators have classified remediate issues. This type of ongoing
devices into varying risk levels, low, education will go a long way to helping
medium and high, it’s vitally important developers understand whether their
for manufacturers of these systems to coding practices are defensive enough
do the best possible job of designing to uphold the reliability of our medical
and writing secure software to ensure devices.
the validity of the healthcare industry.
For many healthcare organisations, A matter of life or death
this kind of risk management applied As software moves to centre stage,
to software development is still a the value of testing, especially in
relatively new idea. the production of devices that are
literally a matter of life of death,
Developer training is a key priority. One thing is clear
Regardless of what tools and – technology will always outrun
technologies an organisation decides the legislation that is put in place
to use, developer awareness and to regulate it. But developers that
training is at the heart of the issue. differentiate themselves by embracing
The reason is that most developers high quality testing methods to
think of software reliability in terms of protect the brand and validity of their
Alen Zukich
Director
whether a particular issue can cause a organisation, will succeed, and may
Klocwork
www.klocwork.com
failure or whether they’ve developed even save lives in the process.
T.E.S.T | June 09 June 09 | T.E.S.T
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