Background - Using Event-B for Critical Device Software Systems - page 28

(ITSEC)), US (Trusted Computer Security Evaluation Criteria (TCSEC)) and Cana-
dian (Canadian Trusted Computer Product Evaluation Criteria (CTCPEC)) [ 19 - 21 ].
The CC enables an objective evaluation to validate that a particular product or sys-
tem satisfies a defined set of security requirements. The CC provides a framework
for the computer users, vendors and testing organisations for fulfil their require-
ments and assures that the process of specification, implementation and testing of a
product has been conducted in a rigorous and standard manner.
There are several ways to tackle the complexity issues of software, which major
the software at industrial scales and usability of the software. The Software Engi-
neering Institute, funded by the military, has produced a Capability Maturity Model
(CMM) [ 90 ] by which may be assessed the quality of management in a software en-
gineering team. The CMM broadly refers to a process improvement approach that
is based on a process model. A process model is a structured collection of prac-
tices that describe the characteristics of effective processes; the practices included
are those proven by experience to be effective. The CMM can be used to assess
an organisation against a scale of five process maturity levels. Each level ranks the
organisation according to its standardisation of processes in the subject area being
assessed.
2.9 Regulations for Medical Devices
All kinds of medical products have to comply with national or international reg-
ulatory bodies that can provide safety assurance to use the medical products. The
pathway from product design to the final product is often unclear and number of
challenges and questions increase as medical device become more complex. The
regulating bodies cover the essential requirements to regulate the standards of safety
and performance of the medical devices. Medical device manufacturers agree to fol-
low medical device development standards to provide the life-saving technologies
to patient without compromising in safety with low cost.
The past decades shows several recalls related to the safety issues in the medical
devices [ 63 ]. Everyday lots of defects are reported by consumers that are a seri-
ous consequence due to medical device failures. Faults in medical devices, such as
pacemakers, defibrillators, artificial hip, and stents, have caused severe patient in-
juries and deaths. In 2006, FDA reported 116,086 device related injuries, 96,485
malfunctions, and 2,830 deaths; a more recent independent analysis claims there
were 4,556 device-related deaths in 2009 [ 45 , 63 ]. These recalls have raised many
questions related to the device development process, designing and testing tools,
and resources are adequate to ensure that the developed device are safe and secure
to use in practice. However, the adoption of medical regulations has increased the
rates of infant mortality, life expectancy, and premature and preventable deaths all
over the world.