上市后临床跟踪管理程序文档格式.docx
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上市后临床跟踪管理程序文档格式.docx
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2.SCOPE
applies
all
device
businesses
and
sites
operating
under
TDI
Healthcare
Quality
Management
System.
Only
Mark
be
follow
work
instruction.
3.REFERENCES
3.1.External
References
3.1.1.Laws
▪Council
Directive
93/42/EEC
14
June
1993
concerning
devices
including
amendments
through
05
September
2007
3.1.2.Guidance
Documents
▪European
Commission
Enterprise-Directorate-General
MEDDEV
2.12-2
Guidelines
on
Post
Market
Clinical
Follow-Up
dated
May
2004
▪MEDDEV
2.7.1
Rev.3
guidelines
device-clinical
evaluation-a
guide
for
manufacturers
notified
bodies
April
2009
▪GHTF
Post-Market
Studies;
SG5(PD)N4R7
(Proposed
23
July
2008)
Investigations;
SG5(PD)N3R7
(20
January
4.ROLES
AND
RESPONSIBILITIES
Important:
When
title
position
listed
in
instruction,
it
relates
to
that
or
its
equivalent.
Below
are
roles
responsibilities
discussed
within
document.
Table
4-1:
Roles
Responsibilities
Role
Design
Engineering
and/or
Representative
Responsibility
Provide
consultation
Product
Regulatory
Affairs
Representative
in
determining
given
project/product
clinical
required
an
equivalent
exists
identifying
emerging
risks
device
Research
Manager
designee
determine
type
implemented,
if
applicable
Regulatory
Determine
give
Identify
potential
risks
Review
risk
assessment
Complete
Justification
Form
regarding
decision
perform
study
Plan
form
details
the
plan
how
often
data
must
reviewed
approve
evaluation
performed
by
Research
designee
Affairs
of
or
identify
confirm
decisions
regarding
need
follow-up
be
new
(i.e.
literature,
adverse
events,
complaints,
etc,)
necessary
based
on
information
(clinical
evaluation)
Medical
Review
5.WORK
INSTRUCTION
Post-market
essential
element
establishing
long
term
safety
possible
emergent
devices.These
cannot
adequately
detected
characterized
relying
solely
pre-market
investigations.
market
may
include
combination
several
strategies:
▪
complaint
review
event
reporting
review
users
patients
Literature
studies
(PMCFS)
This
was
created
when
PMCFS
maintain
adequate
surveillance
system,
as
Medical
Device
93/42/ECC
(MDD)
amended
MDD
2007/47/EC.It
also
is
not
Figure
5-1:
High-Level
Process
Overview
Follow-Up
equivalent
residual
risks/emerging
PMCFS
Determination
Risk
Assessment
document
Evaluate
Required?
YES
NO
Perform
accordance
with
GEHC_GQP_10.03
GEHC_GQP_10.03.002
At
minimum,
data
including,
AE抯
complaints
literature
information
5.1.General
Requirements
5.1.1.Prior
M3
sign-off,
consultation
Engineering
and/or
shall
project/program
a
required.They
also
plan.
5.1.2.A
products
which
medium/long-term
performance
already
known
from
previous
use
where
other
appropriate
activities
would
sufficient
address
risks.
5.2.Determining
Type
Required
have
one
two
outcomes,
(1)
(2)
no
factors
detailed
section.
5.2.1.The
exists.Equivalence
demonstrated
characteristics
precisely
defined
below.
Equivalence
means:
▪Clinical
▪Used
same
condition
purpose;
at
site
body;
similar
population
(including
age,
anatomy,
physiology);
▪Have
relevant
critical
according
expected
effect
specific
intended
use
▪Technical
conditions
use;
specifications
properties;
▪Be
design;
▪Use
deployment
methods
principles
operation
▪Biological
▪Same
materials
contact
human
tissues
body
fluids
5.2.2.Products
medium/long
term
already
device,
fully
transferable
experience
with
require
PMCFS.
NOTE:
If
quoted
“equivalent”
requires
PMCFS,
then
new
product
subject
requirement.
5.2.3.The
determined
identification
residual
impact
risk/benefit
ratio.A
should
always
considered
where
essential.The
Design
such
risk,
following
criteria
taken
into
account:
▪innovation,
e.g.,
design
materials,
principles
operation,
technology
indications
novel;
▪high
anatomical
locations
(i.e.,
heart,
central
nervous
etc.);
▪severity
disease/treatment
challenges;
▪sensitivity
target
infants,
children,
pregnant
women,
▪identification
acceptable
during
pre-CE
evaluation,
monitored
longer
larger
population;
▪well
identified
literature
marketed
devices;
▪discrepancy
between
time
scales
expected
life
product;
5.2.4.A
properly
conducted
analysis
what
evidence
needed
particular
device.Any
“unacceptable”
conclusion
development
PMCFS.
A
considered
“acceptable”
“risk
mitigation
required”
meets
any
5.2.1
5.2.2.The
assessment
Management
Procedure.
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