<s>
The	O
development	O
of	O
the	O
ISO	O
9000-3	O
standard	O
as	O
well	O
as	O
the	O
European	O
Medical	O
Devices	O
Directive	O
in	O
1993	O
helped	O
bring	O
some	O
harmonization	O
of	O
existing	O
laws	O
with	O
medical	O
devices	O
and	O
their	O
associated	O
software	O
,	O
and	O
the	O
addition	O
of	O
IEC	B-Application
62304	I-Application
in	O
2006	O
further	O
cemented	O
how	O
medical	O
device	O
software	O
should	O
be	O
developed	O
and	O
tested	O
.	O
</s>
<s>
The	O
global	O
IEC	B-Application
62304	I-Application
standard	O
on	O
the	O
software	O
life	O
cycle	O
processes	O
of	O
medical	O
device	O
software	O
states	O
it	O
's	O
a	O
"	O
software	O
system	O
that	O
has	O
been	O
developed	O
for	O
the	O
purpose	O
of	O
being	O
incorporated	O
into	O
the	O
medical	O
device	O
being	O
developed	O
or	O
that	O
is	O
intended	O
for	O
use	O
as	O
a	O
medical	O
device	O
in	O
its	O
own	O
right.	O
"	O
</s>
<s>
The	O
dramatic	O
increase	O
in	O
smartphone	B-Application
usage	O
in	O
the	O
twenty-first	O
century	O
triggered	O
the	O
emergence	O
of	O
thousands	O
of	O
stand-alone	O
health	O
-	O
and	O
medical-related	O
software	O
apps	O
,	O
many	O
falling	O
into	O
a	O
gray	O
or	O
borderline	O
area	O
in	O
terms	O
of	O
regulation	O
.	O
</s>
<s>
Examples	O
of	O
mobile	O
apps	O
potentially	O
covered	O
by	O
the	O
guidance	O
included	O
those	O
that	O
regulate	O
an	O
installed	O
pacemaker	B-Device
or	O
those	O
that	O
analyze	O
images	O
for	O
cancerous	O
lesions	O
,	O
X-rays	O
and	O
MRI	B-Algorithm
,	O
graphic	O
data	O
such	O
as	O
EEG	B-Application
waveforms	O
as	O
well	O
as	O
bedside	O
monitors	O
,	O
urine	O
analyzers	O
,	O
glucometer	O
,	O
stethoscopes	O
,	O
spirometers	O
,	O
BMI	O
calculators	O
,	O
heart	O
rate	O
monitors	O
and	O
body	O
fat	O
calculators	O
.	O
</s>
<s>
IEC	B-Application
62304	I-Application
has	O
become	O
the	O
benchmark	O
standard	O
for	O
the	O
development	O
of	O
medical	O
device	O
software	O
,	O
whether	O
standalone	O
software	O
or	O
otherwise	O
,	O
in	O
both	O
the	O
E.U.	O
</s>
