The document provides an overview of a presentation on FDA Design Controls. It introduces the two presenters, David Amor and Jon Speer, who are experts in medical device quality systems and design controls. The presentation will cover topics related to design controls regulations, including intended use, user needs, design inputs, design reviews, risk management, design outputs, design verification and validation, and regulatory submissions. It is meant to help medical device companies understand and comply with FDA design control requirements.

1. The Complete Guide to
FDA Design Controls
Part 1 & 2
April 26th, 2016

2. About the Presenter
David Amor is the co-­‐founder and CEO
of Medgineering & QuickConsult.
• Adjunct Professor, St. Cloud State
University (SCSU) – MTQ628
Design Controls
• 9+ years of QA/RA consulting
including DHF / risk mgmt
remediation projects
• FDA & EU expert in QMS
@medgineering
david@medgineering.com
786.546.1806
Medgineering is a medtech consulting firm
based in Minneapolis, MN focusing on
regulatory submissions and quality systems.
www.medgineering.com
www.21cfr820.com
Online medtech consulting marketplace – on
demand experts for Q&A and projects!
www.myquickconsult.com

3. About the Presenter
Jon Speer is the Founder & VP QA/RA
of greenlight.guru.
• 17+ years in medical device industry
• Product development engineer,
quality manager, regulatory
specialist
• 40+ products to market
• Expert at QMS implementations
• Dozens of ISO audits & FDA
inspections
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280
greenlight.guru produces beautifully simple
quality, design control and risk management
software exclusively for medical device
manufacturers. We help you bring higher
quality devices to market faster and with less
risk.
http://greenlight.guru

4. In
Part
1,
you'll
learn
about
Intended
Use,
User
Needs,
Design
Inputs,
Design
Reviews,
Design
History
File
(DHF)
and
Risk
Management.
Specifically:
• The
importance
of
getting
your
intended
use
right
up
front
• The
difference
between
a
user
need
and
a
design
input
that's
verifiable
• What
stakeholders
need
to
be
involved
in
the
process
and
why
• When
and
how
many
design
reviews
you
should
hold
• Why
FMEA
alone
is
NOT
risk
management
and
how
to
integrate
risk
into
the
design
and
development
process

5. In
Part
2,
you'll
learn
about
Design
Outputs,
Device
Master
Record
(DMR),
Design
Verification
and
Validation
(V&V),
Design
Transfer
and
Regulatory
Submissions.
Specifically:
• Why
your
design
outputs
need
to
be
more
than
a
drawing
and
their
relationship
to
your
DMR
• How
usability
and
human
factors
fits
into
the
overall
product
development
• Making
sure
you
build
the
correct
device
and
build
it
correctly
with
design
V&V
• Common
mistakes
people
make
during
design
transfer
to
production
and
how
to
avoid
them
• When
you
can
and
should
make
your
regulatory
submission

6. Design Controls
An introduction

7. 1997.

8. 21 CFR 820.30.

10. Design Controls – when?
Any
Class
II
or
Class
III
medical
device
developed
in
the
US
– part
of
quality
system
(QMS).
Investigational
Device
Exemption
(IDE)
– 21
CFR
812.

14. User Needs & Design Input
The FDA differentiates between
user needs and technical requirements

15. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
Use
a
development
plan.
Keep
it
short
and
sweet.
Don’t
overcommit
and
don’t
make
it
too
prescriptive.
820.30
Design
Controls Design
Planning

16. 820.30
Design
Controls Design
Planning
The
extent
of
design
and
development
planning
should
reflect
company
size
and
complexity
and
any
outsourcing.
• Refining
is
OK
– especially
for
new
portfolio
products
• Identify
key
milestones
and
dates
only
• Detail
should
be
dependent
on
risk
• If
outsourcing
development
work,
identify
the
resources
and
integration

17. 820.30
Design
Controls Design
Planning
“You
state
in
your
response
that
you
plan
on
making
your
design
plan
more
robust.
We
would
like
to
clarify
that
this
plan,
as
per
21
CFR
820.30(b),
“shall
identify
and
describe
the
interface
between
groups
that
provide,
or
result
in,
input
to
the
design
development
process.
The
plans
shall
be
reviewed,
updated,
and
approved
as
design
and
development
evolves.”
The
design
plan
for
Avex
CX2
and
CXi2,
reviewed
during
the
current
inspection,
was
observed
to
lack
this
data
including,
but
not
limited
to,
completed
and
approved
plans
for:
Development,
Clinical,
Risk
Management,
Quality
Processing,
Manufacturing,
and
Manufacturing
Qualification”
Discussion
Point:
Lack
of
documented
planning
shows
poor
oversight
of
your
processes.
Development
planning
may
change
with
new
information
– up
to
the
point
of
design
freeze.

18. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
Design
inputs
need
to
be
organized
and
differentiated
between
users,
customers
and
stakeholders.
Design
inputs
must
be
clear
and
verifiable.
820.30
Design
Controls Design
Inputs

19. 820.30
Design
Controls Design
Inputs
Design
requirements
are
the
single
most
important
factor
in
820.30
“There’s
never
time
to
do
it
right
but
there’s
always
time
to
do
it
over!”
• Comprehensive
– per
risk
• Methodical
• Linked
to
clinical
or
other
rationale

20. 820.30
Design
Controls Design
Inputs
“Drilling
down”
inputs
is
critical.
• Refining
is
OK
– especially
for
new
portfolio
products
• Identify
key
milestones
and
dates
only
• Detail
should
be
dependent
on
risk
• If
outsourcing
development
work,
identify
the
resources
and
integration

21. 820.30
Design
Controls Design
Inputs
“Drilling
down”
inputs
is
critical.
User
Needs
Marketing
Needs
Customer
Needs
Other
Stakeholder
Needs
“Concept”
Documents
per
FDA
Guidance
1997
Design
Controls

22. 820.30
Design
Controls Design
Inputs
Am
I
ever
going
to
tell
you
that
I
need
a
catheter
with
a
tensile
strength
of
10
+/-­‐ 2
N?
“Drilling
down”
inputs
is
critical.
User
Needs
Marketing
Needs
Customer
Needs
Other
Stakeholder
Needs

23. 820.30
Design
Controls Design
Inputs
Product
Requirements
• Solution
independent
• Clear
• Concise
• Verifiable
“Drilling
down”
inputs
is
critical.
User
Needs
Marketing
Needs
Customer
Needs
Other
Stakeholder
Needs

24. 820.30
Design
Controls Design
Inputs
“Drilling
down”
inputs
is
critical.
User
Needs
Marketing
Needs
Customer
Needs
Other
Stakeholder
Needs
Product
Requirements
Specifications
WHAT? HOW!

25. 820.30
Design
Controls Design
Inputs
The
catheter
shall
be
easy
to
manipulate.
The
catheter
shall
have
a
torque
ratio
of
1:1
User
Need
(Requirement)
Design
Input
(Requirement)
Design
Output
(Specification)
Material
specifications
Test
methods
Drawings

26. 820.30
Design
Controls Design
Inputs
Design
Input
(Requirement)
The
catheter
shall
have
a
torque
ratio
of
1:1
This
may
involve
iterative
testing
until
the
design
input
requirement
is
determined.
• TBD
in
initial
drafts
of
DI
documents
are
acceptable
–
help
guide
feasibility
testing!
• May
shift
over
time
• Impact
assessment

27. 820.30
Design
Controls Design
Inputs
“Failure
to
establish
and
maintain
adequate
procedures
to
ensure
that
the
design
requirements
relating
to
a
device
are
appropriate
and
address
the
intended
use
of
the
device,
including
the
needs
of
the
user
and
patient,
as
required
by
21
CFR
820.30(c)”
Discussion
Point:
When
you
create
a
user
needs
/
requirement
document,
are
you
linking
it
back
to
the
intended
use
of
the
device?

28. 820.30
Design
Controls Design
Inputs
Design
Inputs
must
be
clear
(unambiguous)
and
verifiable.
• If
basing
design
inputs
on
a
standard,
make
sure
the
standard
reference
is
specific,
clear,
and
test-­‐able
• When
you
think
of
design
inputs,
think
“engineering”
and
“getting
technical”
• Find
a
resource
for
writing
requirements

29. 820.30
Design
Controls Design
Inputs
Design
Inputs
must
be
clear
(unambiguous)
and
verifiable.
“Device
shall
be
portable”….

30. 820.30
Design
Controls Design
Inputs
Design
Inputs
must
be
clear
(unambiguous)
and
verifiable.
“Device
shall
be
compliant
to
ISO
10993-­‐1…”

31. 820.30
Design
Controls Design
Inputs
Design
Inputs
must
be
clear
(unambiguous)
and
verifiable.
Device
shall
be
flexible
Device
shall
be
formed
into
a
50
mm
diameter
coil
and
straightened
out
for
a
total
of
50
times
with
no
evidence
of
cracking
or
deformity.
NOTE: assess
the
level
of
granularity
or
detail
based
on
requirement
criticality/
risk.
VS

32. 820.30
Design
Controls Design
Inputs
F
P
I
S.
• Functional:
what
does
the
device
do?
• Performance:
accuracy,
conditions,
operational
limits,
reliability,
etc.
• Interface:
what
does
the
device
need
to
have
to
work
with
accessories
or
external
items?
• Safety:
does
the
device
need
precautionary
measures
or
safety
margins?

33. A
note
on
drafting
requirements.
• Language
is
important
a) ‘Shall’
vs.
‘Should’
a) “Must
have”
vs.
“Nice
to
have”
b) Avoid
“as
applicable”
or
“as
required”
in
final
DI
• Avoid
contradicting
requirements
• System
à sub-­‐system
a) Particularly
useful
for
contracting
820.30
Design
Controls Design
Inputs

34. A
note
on
drafting
requirements.
• Avoid
comparative
requirements
• Ex:
“…shall
be
20%
better
than
the
predicate.”
• Avoid
multiple
objectives
in
same
requirement
• Avoid
“NOTEs”!!!
• INCOSE
“Writing
technical
requirements”
820.30
Design
Controls Design
Inputs

35. 820.30
Design
Controls Design
Inputs
Don’t
stress
about
documenting
design
inputs
in
proof
of
concept
or
feasibility
phases.
Be
agile!
• FDA
distinguishes
between
R&D
and
finished
product
– remember
this!
• Design
inputs
apply
to
the
commercial
product
(“how
do
I
know
the
design
is
in
control?”)

36. The importance of traceability.
“Failure
to
establish
and
maintain
adequate
procedures
for
verifying
the
device
design,
as
required
by
21
CFR
820.30(f).
Specifically,
design
outputs
were
not
always
evaluated
to
demonstrate
that
the
outputs
met
design
inputs.”

38. Risk Management
An overview

39. Risk
Management Design
Controls
Intended
Use
is
important
for
Design
Controls
&
Risk
Management.
Risk
Management
&
Design
Controls
are
about
demonstrating
a
medical
device
is
SAFE
and
EFFECTIVE.

40. Risk
Management Design
Controls
Product
Risk
Management
is
a
cycle,
even
during
product
development.
• Start
Risk
Management
process
early
• Use
Risk
Management
process
to
improve
product
design
• Use
Design
Controls
to
support
Risk
Controls
/
Mitigations

42. RISK
MANAGEMENT-­‐ systematic
application
of
management
policies,
procedures,
and
practices
to
the
tasks
of
analyzing,
evaluating,
controlling,
and
monitoring
risk
RISK -­‐ combination
of
the
probability
of
occurrence
of
harm
and
the
severity
of
that
harm
ISO
14971
Risk
Management Key
Terms

43. HAZARD -­‐ potential
source
of
harm
HAZARDOUS
SITUATION -­‐ circumstance
in
which
people,
property,
or
the
environment
are
exposed
to
one
or
more
hazard(s)
HARM -­‐ physical
injury
or
damage
to
the
health
of
people,
or
damage
to
property
or
the
environment
SEVERITY -­‐ measure
of
the
possible
consequences
of
a
hazard
ISO
14971
Risk
Management Key
Terms

44. RISK
ANALYSIS -­‐ systematic
use
of
available
information
to
identify
hazards
and
to
estimate
the
risk
RISK
ESTIMATION -­‐ process
used
to
assign
values
to
the
probability
of
occurrence
of
harm
and
the
severity
of
that
harm
RISK
EVALUATION -­‐ process
of
comparing
the
estimated
risk
against
given
risk
criteria
to
determine
the
acceptability
of
the
risk
RISK
ASSESSMENT -­‐ overall
process
comprising
a
risk
analysis
and
a
risk
evaluation
RISK
CONTROL -­‐ process
in
which
decisions
are
made
and
measures
implemented
by
which
risks
are
reduced
to,
or
maintained
within,
specified
levels
RESIDUAL
RISK -­‐ risk
remaining
after
risk
control
measures
have
been
taken
ISO
14971
Risk
Management Key
Terms

45. ISO
14971
Risk
Management Process
Overview

46. ISO
14971
Risk
Management Establish
Framework

47. ISO
14971
Risk
Management Risk
Analysis

48. ISO
14971
Risk
Management Risk
Analysis
I
can
be
a
valuable
resource
throughout
the
Risk
Management
Process!
Include
end-­‐users
as
part
of
the
process.
Hazards
Foreseeable
Sequence
of
Events
Hazardous
Situations
Harms

49. ISO
14971
Risk
Management Risk
Evaluation

50. ISO
14971
Risk
Management Risk
Evaluation
Risk
Evaluation
criteria
shall
be
established
and
should
be
specific
to
your
product.
• Use
sources
like
MAUDE
and
other
industry
databases.
• Consult
with
end-­‐users
to
understand
true
severity.
• Evaluate
other
similar
products.
• Leverage
standards
and
guidance
documents.

51. ISO
14971
Risk
Management Risk
Assessment

52. ISO
14971
Risk
Management Risk
Assessment

53. ISO
14971
Risk
Management Risk
Control

54. ISO
14971
Risk
Management Risk
Control
Risk
Controls
are
means
to
demonstrate
risks
have
been
reduced
to
acceptable
levels.
Priority
of
Risk
Control
options:
1. Inherent
safety
by
design
2. Protective
measures
in
the
medical
device
itself
or
in
the
manufacturing
process.
3. Information
for
safety.
Recommend
identifying
Risk
Controls
for
ALL risks.

55. ISO
14971
Risk
Management Risk
Control
My
Design
Outputs,
Design
Verifications,
and
Design
Validations
can
be
used
as
Risk
Control
Measures.

57. ISO
14971
Risk
Management Risk
Acceptability

58. ISO
14971
Risk
Management Risk
Acceptability
Have
me
help
you
with
risk
/
benefit
analysis
of
your
product.
Medical
benefits
of
the
medical
device
need
to
outweigh
the
risks
to
patients
and
end-­‐users.

59. ISO
14971
Risk
Management Risk
Management
Report

60. ISO
14971
Risk
Management Production
/
Post-­‐Production

61. Design Review
An overview

62. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
Design
reviews
shall
be
planned
and
conducted
at
appropriate
stages
during
medical
device
product
development.
820.30
Design
Controls Design
Review

63. 820.30
Design
Controls Design
Review
“Failure
to
document
the
design
review
results,
including
the
date,
in
the
design
history
file,
as
required
by
21
CFR
820.30(e).”
“Design
reviews
were
not
performed
and/or
documented
for
the
.
.
.design
project
as
required
in
the
work
instruction
or
the
design
plan.”
“Design
reviews
were
conducted;
however,
the
records
fail
to
indicate
the
date
or
dates
the
design
reviews
were
conducted
and
fail
to
indicate
the
results
of
the
design
reviews
as
required
in
the
work
instruction.
“However,
there
were
no
records
of
any
design
reviews
having
been
conducted
after
the
design
changes
were
implemented
or
transferred
to
production.”

64. 820.30
Design
Controls Design
Review
Timing
of
design
reviews
is
a
function
of
design
planning.
Frequency
of
design
reviews
should
reflect
complexity
of
product
development.
• All
design
controls
need
to
be
part
of
design
reviews.
• Design
plan
shall
identify
when
design
reviews
are
to
happen.
• Design
reviews
shall
include
an
“independent
reviewer”.
• Design
reviews
shall
include
appropriate
functions.

66. Design History File
What goes in DHF?

67. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
DHF
contains
documented
evidence
that
medical
device
was
developed
according
to
established
design
plan.
DHF
contains
all
design
controls.
820.30
Design
Controls Design
History
File
(DHF)

68. 820.30
Design
Controls Design
History
File
(DHF)
“Failure
to
establish
and
maintain
a
design
history
file
for
each
type
of
device,
as
required
by
21
CFR
820.30(j). For
example,
your
firm
was
unable
to
demonstrate
when
key
elements
of
a
design
history
file
for
the
design
project
were
conducted
and
approved,
such
as
design
inputs,
outputs,
verification,
validation,
and
design
transfer.”

69. 820.30
Design
Controls Design
History
File
(DHF)
If
it
isn’t
documented,
then
it
didn’t
happen.
Document
all
Design
Controls
and
keep
records
in
an
organized
DHF.
• Establish
a
DHF
per
product.
• Use
Design
Reviews
to
confirm
Design
Controls
have
been
documented.
• Compile
DHF
into
a
“single
source
of
truth”.

70. 820.30
Design
Controls Design
History
File
(DHF)
It
is
my
responsibility
to
document
design
controls
and
maintain
the
DHF.

71. Q&A
Part 1

72. David Amor
@medgineering
david@medgineering.com
786.546.1806
www.medgineering.com
www.21cfr820.com
www.myquickconsult.com
Jon Speer
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280
Quality Management Software
Exclusively for Med Devices
http://greenlight.guru
Getting in Touch

73. The Complete Guide to
FDA Design Controls
Part 2

74. In
Part
2,
you'll
learn
about
Design
Outputs,
Device
Master
Record
(DMR),
Design
Verification
and
Validation
(V&V),
Design
Transfer
and
Regulatory
Submissions.
Specifically:
• Why
your
design
outputs
need
to
be
more
than
a
drawing
and
their
relationship
to
your
DMR
• How
usability
and
human
factors
fits
into
the
overall
product
development
• Making
sure
you
build
the
correct
device
and
build
it
correctly
with
design
V&V
• Common
mistakes
people
make
during
design
transfer
to
production
and
how
to
avoid
them
• When
you
can
and
should
make
your
regulatory
submission

75. Design Outputs & DMR
Design Outputs – more than just drawings!

76. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
Design
outputs
aren’t just
specifications
and
drawings.
820.30
Design
Controls Design
Outputs

77. 820.30
Design
Controls Design
Outputs
What
can
I
show
you
in
my
books
to
demonstrate
that
the
design
inputs
are
being
met/
fulfilled/
satisfied
– how
can
I
prove
it?

78. • “Establish
and
maintain
procedures
for
documenting
design
output
in
terms
that
allow
an
adequate
evaluation
of
conformance
to
design
input
requirements”
820.30
Design
Controls Design
Outputs
• PLAIN
ENGLISH:
“We
need
a
documented
way
to
show
how
we
show
that
our
design
inputs
are
met
– a
drawing,
a
specification,
results
of
a
test,
methods,
etc.”

79. • “Design
output
procedures
shall
contain
or
make
reference
to
acceptance
criteria….”
820.30
Design
Controls Design
Outputs
• PLAIN
ENGLISH:
How
do
we
know
a
design
input
requirement
is
met?
Acceptance
criteria.
The
output
must
be
clearly
marked
to
be
able
to
show
this!

80. • “and
shall
ensure
that
those
design
outputs
that
are
essential
for
the
proper
functioning
of
the
device
are
identified.”
820.30
Design
Controls Design
Outputs
• PLAIN
ENGLISH:
‘Essential
for
proper
functioning’
means
you
should
know
the
Intended
Use
and
what
design
aspects
are
most
critical
to
meet
it.

81. 820.30
Design
Controls Design
Outputs
Design
outputs:
format
and
type
Drawings
Material
Specification
Inspection
reports.
Service
instructions.
Mfg
Instructions
Batch
Records
Testing
instructions.
Software
code.
QA
specs/
procedures.
Packaging/
Labeling.
Risk
Mgmt
File
Test
results.

82. 820.30
Design
Controls Design
Outputs
“Failure
to
establish
and
maintain
adequate
procedures
for
verifying
the
device
design,
as
required
by
21
CFR
820.30(f).
Specifically,
design
outputs
were
not
always
evaluated
to
demonstrate
that
the
outputs
met
design
inputs.”
Discussion
Point:
Some
companies
use
DOORS
or
other
similar
requirements
traceability
programs
– what
are
the
pros
and
cons
with
those
programs?

83. 820.30
Design
Controls Design
Outputs
”For
example,
change
summary
report,
DP#05-­‐11
– “ICL
Change
of
Packaging
Solution
from
(b)(4) to
(b)(4)”
lacks
the
necessary
attachments,
references
and
reports
necessary
to
compare
the
design
inputs
with
the
design
outputs
and
determine
the
adequacy
of
the
verification.”
Discussion
Point:
Some
companies
use
DOORS
or
other
similar
requirements
traceability
programs
– what
are
the
pros
and
cons
with
those
programs?

84. The
total
finished
design
output
consists
of
the
device,
its
packaging
and
labeling,
and
the
device
master
record.
820.30
Design
Controls Design
Outputs
The
DMR
is
the
“one
stop
shop”
for
design
outputs,
often
maintained
in
a
DMR
Index.

85. Design Verification &
Design Validation
An overview

87. 820.30
Design
Controls Design
Verification
Did
I
design
my
medical
device
correctly?
Design
Input
(Requirement)
Design
Output
(Specification)
Design
Verification

88. 820.30
Design
Controls Design
Validation
Did
you
design
the
correct
medical
device?
User
Needs Medical
Device Design
Validation

90. 820.30
Design
Controls Design
Verification
“Failure
to
establish
and
maintain
adequate
procedures
for
verifying
the
device
design. Design
verification
shall
confirm
that
the
design
output
meets
the
design
input
requirements,
as
required
by
21
CFR
820.30(f). For
example:
Your
firm
failed
to
validate
test
methods
implemented
during
design
verification
testing. These
test
methods
were
created
in-­‐house
to
verify
your
firm’s
design
inputs;
however,
they
were
not
based
on
and
did
not
follow
a
national
standard.
Your
firm
failed
to
follow
its
test
procedure
during
design
verification
testing.
Your
firm
performed
design
verification
prior
to
establishing
design
inputs.”

91. 820.30
Design
Controls Design
Validation
“Your
firm
failed
to
establish
(i.e.,
define,
document,
and
implement)
and
maintain
design
validation
procedures
to
ensure
that
devices
conform
to
defined
user
needs
and
intended
uses
and
shall
include
testing
of
production
units
under
actual
or
simulated
use
conditions,
as
required
by
21
CFR
820.30(g).
For
example,
your
firm
failed
to
implement
its
established
procedure
for
design
validation.
.
. However,
prior
to
commercially
releasing
your
product,
your
firm
failed
to
conduct
design
validation
of
the
device
constituent
part
of
this
combination
product,
as
required
by
your
SOP. ”

92. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
Design
Verification
demonstrates
that
the
medical
device
Design
Outputs
meet
the
Design
Inputs.
820.30
Design
Controls Design
Verification

93. 820.30
Design
Controls Design
Verification
Design
Verification
shall
provide
clear,
objective
evidence
that
Design
Outputs
meet
Design
Inputs
• Consider
Design
Verification
when
defining
Design
Inputs
• Establish
a
Design
Verification
Plan
(and
do
so
early)
• Define
verification
methods
• Demonstrate
acceptance
criteria
is
met

94. 820.30
Design
Controls Design
Verification
The
catheter
shall
have
a
torque
ratio
of
1:1
Design
Input
(Requirement)
Design
Output
(Specification)
Material
specifications Plans
Drawings
Design
Verification
Results
Methods

95. 820.30
Design
Controls Design
Verification
Testing
Inspection
Analysis
Design
Verification
Plan
Design
Verification
Methods

97. 820.30
Design
Controls Design
Verification
• Design
Inputs
must
be
clear
(unambiguous)
and
verifiable.
• Design
Outputs
must
be
defined
so
that
conformance
to
Design
Inputs
may
be
demonstrated.
• Need
to
establish
“acceptance
criteria”.
• Establish
(and
validate)
Design
Verification
methods.

98. 820.30
Design
Controls Design
Verification
Testing
Inspection
Analysis
Design
Verification
Plan
Results
Design
Verification
Methods

100. 820.30
Design
Controls Design
Verification
Did
I
design
my
medical
device
correctly?
Design
Input
(Requirement)
Design
Output
(Specification)
Design
Verification

101. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
Design
Validation
demonstrates
that
the
medical
device
meets
the
needs
of
the
end-­‐
user(s).
820.30
Design
Controls Design
Validation

102. 820.30
Design
Controls Design
Validation
Design
Validation
shall
provide
clear,
objective
evidence
that
the
medical
device
meets
the
needs
of
the
end-­‐users.
• Establish
a
Design
Validation
Plan
(and
do
so
early)
• Use
regulatory
product
classification
• Involves
“clinical
evaluation”
in
actual
or
simulated
use
with
actual
end-­‐users
• Product
is
production
equivalent
• Includes
the
entire
product,
including
packaging
and
labeling

103. 820.30
Design
Controls Design
Validation
• “Clinical
evaluation”
does
NOT
just
mean
actual
use.
• Actual
use
will
likely
require
addressing
additional
regulatory
criteria.
• For
many
devices,
simulated
use
is
more
than
sufficient.

104. 820.30
Design
Controls Design
Validation
User
Needs Medical
Device
Plans
Design
Validation
Results
Methods
The
catheter
shall
be
easy
to
manipulate.

105. 820.30
Design
Controls Design
Validation
TESTING!!
Inspection
Analysis
Design
Validation
Plan
Design
Validation
Methods

107. 820.30
Design
Controls Design
Verification
• Design
Inputs
must
be
clear
(unambiguous)
and
verifiable.
• Design
Outputs
must
be
defined
so
that
conformance
to
Design
Inputs
may
be
demonstrated.
• Need
to
establish
“acceptance
criteria”.
• Establish
(and
validate)
Design
Verification
methods.

108. 820.30
Design
Controls Design
Validation
TESTING!!
Inspection
Analysis
Design
Validation
Plan
Results
Design
Validation
Methods

110. 820.30
Design
Controls Design
Validation
Did
you
design
the
correct
medical
device?
User
Needs Medical
Device Design
Validation

111. Design Transfer
Not an event – but a process!

112. Regulation Description
21CFR
820 Quality
System
Regulation
Subpart C Design
Controls
Design
transfer
is
the
translation
of
all
of
the
design
work
to
the
production
and
testing
processes
that
will
make
it
commercial-­‐izable.
820.30
Design
Controls Design
Transfer

113. • Myth:
Design
Transfer
is
an
event
• Reality:
Design
Transfer
is
an
iterative,
continuous
process
• Myth:
Design
Transfer
is
Operations’
responsibility
• Reality:
Design
Transfer
is
a
collaborative
effort
between
all
of
the
functions
involved
in
design
and
development
• Myth:
Design
Transfer
occurs
after
“design
freeze”
• Reality:
Design
Transfer
begins
early
in
design
and
development,
and
is
part
of
design
refinements
(design
changes)
that
lead
to
a
“final”
design.
Design
Transfer
can
not
end
until
the
DMR
is
finalized.
Design
Transfer
Myths
820.30
Design
Controls Design
Transfer

114. Source
of
Misconceptions
21
CFR
Part
820.30
Design
Control
b) Design
&
Development
Planning
c) Design
Input
d) Design
Output
e) Design
Review
f) Design
Verification
g) Design
Validation
h) Design
Transfer
i) Design
Changes
Which
gets
visualized
as:
Planning
Design
Input
Design
Output
Design
Review
Design
Verification
Design
Validation
Design
Transfer
But
the
process
really
looks
more
like
this:
Design
&
Development
Planning
Design
Input
Design
Output
Design
Verification
Design
Validation
Design
Transfer
Design
Review
820.30
Design
Controls Design
Transfer

115. Design
Transfer
Completion
• All
Device
Master
Record
(DMR)
elements
reviewed,
approved,
and
production
released
• All
(DMR)
elements
are
managed
under
formal
change
control
• Risk
assessments
completed
and
all
identified
risks
appropriately
dispositioned
• Defined
and
implemented
test
strategy
for
incoming,
in-­‐process,
and
final
acceptance
testing
• Plans
in
place
to
monitor
and/or
control
features
identified
as
critical
to
quality
• Process
validation
complete
• Test
methods
validated
and
complete
• Inspection
procedures,
visual
inspections,
and
workmanship
standards
are
complete
• Installation
and
servicing
procedures
are
complete
• All
equipment
identified
and
calibrated
and
maintenance
procedures
are
in
place
• Manufacturing
personnel
and
inspectors
have
been
trained
• All
supplier
agreements
and
qualifications
are
complete
• Procedures
in
place
to
ensure
control
of
device
handling,
storage
and
distribution
of
product
• Procedures
in
place
to
ensure
identification
and
traceability
of
product
• Design
verification
testing
performed
and
demonstrates
design
outputs
meet
design
inputs
• Design
validation
testing
performed
demonstrates
design
meets
user
needs
&
intended
uses
• All
elements
of
the
Design
Transfer
Plan
have
been
completed
or
otherwise
addressed
820.30
Design
Controls Design
Transfer

116. 820.30
Design
Controls Design
Transfer
Discussion
Point:
a
process
should
identify
what
represents
“accurate
translation”
of
the
device
design.
“There
is
no
assurance
that
a
design
transfer
procedure
has
been
adequately
established
for
[PRODUCT]
to
[…]
ensure
an
accurate
translation
of
the
device
design
and
conformance
to
predefined
user
needs
and
intended
uses.
There
is
no
assurance
that
design
transfer
procedures
have
been
adequately
established
for
each
rework/reconfiguration
process
of
Passport
V
Monitor
to
ensure
an
accurate
translation
of
the
device
design.”

117. Regulatory Submissions
The DHF forms the basis for your objective evidence
that the device has been designed to be
safe and effective

118. Who
are
the
regulators?
United
States
European
Union
DOJ
enforcement

119. US
Device
Classifications
21
CFR
860
• Classified
according
to
risk
and
“criticality”
to
patient/
end-­‐user
• (3)
letter
code
groupings
with
names
and
attributes
• Used
to
track
adverse
events
and
field
actions
• As
new
classification
product
codes
are
created,
a
device
may
be
re-­‐
assigned
into
a
new
product
code.
• Guidance
exists
for
identifying
the
scope
and
critical
aspects
of
a
product
code.

120. Class
I Class
II Class
III
not
intended
to
help
support
or
sustain
life
or
be
substantially
important
in
preventing
impairment
to
human
health,
and
may
not
present
an
unreasonable
risk
of
illness
or
injury
more
critical
than
Class
I
but
designed
to
perform
as
indicated
without
causing
injury
or
harm
to
patient
or
user.
support
or
sustain
human
life,
are
of
substantial
importance
in
preventing
impairment
of
human
health,
or
present
a
potential,
unreasonable
risk
of
illness
or
injury
LOW
RISK MEDIUM RISK HIGH
RISK
General
Controls General
Controls
+
Special
Controls
510(k)
General
Controls
+
Premarket
Approval
(PMA)

121. General
Controls
• Basic
requirements
for
all
medical
device
companies
per
MDA
• Applies
to
all devices;
Class
I
only has
to
follow
general
controls
(with
some
exceptions)
• Includes
provisions:
• Adulteration
• Misbranding
• Device
registration
and
listing
• Premarketing
notification
(exemptions
in
XXX.9s)
• Banned
devices
• Notification
– repair,
replacement,
refund
• Records
and
reports
• Restricted
devices
• GMPs
(Quality
System
Regulation)-­‐ some
exemption

122. Class
I Class
II Class
III

123. Why
do
I
need
to
comply
to
ISO
13485?
Submitting
a
Medical
Device
in
United
States
General
controls
+
510(k)
or
PMA
depending
on
risk
and
intended
use
of
device
Implement
a
quality
management
system
21
CFR
820
(QSR)
Registration
&
Submission

124. Pre-­‐market
notification
The
2
main
pathways
of
getting
to
US
market.
Pre-­‐market
approval
(PMA)

125. The
510(k)
– Substantial
Equivalence
Substantial
Equivalence
Technological
Characteristics
Intended
Use= &
or
Different
Technological
Characteristics
No
new
safety
or
efficacy
concerns
+

126. Pre-­‐market
notification
Traditional
Special
(20%)
Abbreviated
(5%)

127. 510(k)
Content
(21
CFR
807.87)
• Admin
paperwork
(cover
pages,
statements
• Device
information:
name,
intended
use,
classification
• Company
information:
location,
certifications
• Labeling
• Substantial
equivalence
assessment
o Device
specifications
and
reference
applicable
guidance
documents,
special
controls,
or
standards;
photographs
or
engineering
drawings
o Testing
data
o Comparison
charts
• Information
on
biocompatibility,
sterilization,
materials
analysis,
etc.

128. 510(k)
Data
http://www.emergogroup.com/resources/research/fda-­‐510k-­‐review-­‐times-­‐research

129. The
SE
Letter.

130. Q&A
Part 2

131. David Amor
@medgineering
david@medgineering.com
786.546.1806
www.medgineering.com
www.21cfr820.com
www.myquickconsult.com
Jon Speer
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280
Quality Management Software
Exclusively for Med Devices
http://greenlight.guru
Getting in Touch