Boston Scientific Corporation CRM312004 用户手册
Instructions For Re
vie
w
The tab
le
b
e
lo
w w
a
s desi
gned
to he
lp strea
m
line
the li
te
ra
ture re
vi
e
w
proce
s
s
,
to redu
ce the
n
u
mb
er
o
f re
vie
w
s per pie
c
e of li
te
rature
,
to redu
ce the
a
m
o
unt of
time y
ou ne
ed
to spen
d re
vie
wing
e
a
ch pie
c
e
, and
to hel
p y
o
u
fo
cus y
our atte
ntion wh
ile re
vie
w
ing literature
.
Sug
g
ested Areas
of F
o
cu
s
C
linicals
Te
c
h
Com
m
Desig
n
Eng
ineer
L
e
gal
M
arketing
Pa
c
k
a
g
e
Desig
n
Pr
o
ject
Mana
g
e
r
Reg
F
CE
V
e
ri
fy
ag
ainst
clin
ica
l p
rot
ocol
X
X
X
Prod
uct descr
ip
ti
on,
pr
oduct
h
andli
ng (ste
rilizat
ion
, shipp
ing,
st
or
a
ge)
X
X
Prod
uct specif
icati
ons
, unit
s
o
f meas
ur
e
(i
n tab
les and
t
h
rou
ghou
t te
xt
)
X
X
Prod
uct f
e
a
tur
es—ap
p
rop
riat
e
f
eat
ure
s
hig
h
ligh
te
d? descr
ibe
d
co
rrect
ly?
a
n
y
feat
ure
s
o
v
er
lo
ok
ed
?
XX
X
X
X
X
Ill
u
str
a
ti
ons
a
ppro
p
ri
a
te
t
o
co
rrespo
nding
t
e
xt
and lab
e
led corre
ct
ly?
X
X
X
X
X
T
a
b
le
s
an
d
te
xt rela
tin
g
t
o
par
amet
ers
,
to
ler
ances
, pro
duct f
uncti
ons
cor
rect
?
X
X
X
Re
vie
w
cau
tio
ns
an
d not
es—ap
p
rop
riat
e? ne
ce
ssar
y? an
y
missing?
X
X
X
X
X
X
Imp
lant
p
rocedu
res cor
rect?
X
X
X
Equi
pment
hook-up
p
rocedur
es
, lead
-to
-PG conn
ectio
n
s
, etc.
X
X
X
X
Are re
fe
ren
c
e
s
t
o
o
th
e
r Guid
ant
p
roduct
s
st
ill c
o
rrect
a
nd rele
v
ant
?
X
X
X
X
X
Is inf
o
in t
h
is
lite
ra
tu
re consist
ent
wit
h ot
her rel
a
te
d lite
rat
ure
(l
eads
, pg
)?
X
X
X
X
X
X
Ref
e
re
nces
to
ot
her pro
ducts
af
fe
ct ot
her
submi
s
sion
s?
X
X
X
X
Liab
ilit
y
issues
b
a
sed on claims made in lit
er
a
tur
e
X
X
X
W
a
rr
an
ty inf
o
rm
at
ion correct
?
XX
Has
an
y inf
o
rm
at
ion t
hat
shou
ld be includ
ed been
o
v
er
look
e
d
(
feat
ures
,
sp
ecs
, g
o
v
e
rn
men
t
requ
ireme
n
ts
, le
gal
requ
iremen
ts)?
XX
X
X
X
X
X
X
X
List of
ite
m
s pac
kag
ed with
p
roduct
(
is
the list
corr
ect? an
yt
hing
missing?
)
X
X
X
Does
th
e
pi
ece
o
f lit
er
a
tur
e match t
he documen
tat
ion
spe
c
s? corre
ct
si
z
e?
X
X
X
V
e
ri
fy
pa
rt
n
u
mbe
r o
f
lit
er
a
tur
e
.
Lab
els:
app
ropr
iat
e
mfg
code
s
, A
CNs
,
et
c.
X
X
V
e
ri
fy
cop
y
ri
g
h
t
and
t
ra
demar
k
no
tat
ion
s
X
X
X
Adhe
rence t
o
lite
rat
ure
/comm
u
n
icat
ions st
and
ards
X
Punct
uat
ion
, consiste
ncy in t
reat
ment
of pro
duct
na
mes
, par
a
m
et
er
, et
c.
X
Guid
ant
a
ddre
s
s
, ph
one n
u
m
b
e
rs
, w
a
rr
a
n
ty la
y
out
f
o
rm
at
s
cor
rect?
X