Design Controls PDF

The Complete Guide to
FDA Design Controls

Part 1 & 2
April 26th, 2016

About the Presenter
David Amor is the co-‐founder and CEO Medgineering is a medtech consulting firm
of Medgineering & QuickConsult. based in Minneapolis, MN focusing on
• Adjunct Professor, St. Cloud State regulatory submissions and quality systems.
University (SCSU) – MTQ628
www.medgineering.com
Design Controls
• 9+ years of QA/RA consulting www.21cfr820.com
including DHF / risk mgmt
remediation projects
• FDA & EU expert in QMS
Online medtech consulting marketplace – on
demand experts for Q&A and projects!
@medgineering
david@medgineering.com www.myquickconsult.com
786.546.1806
About the Presenter
Jon Speer is the Founder & VP QA/RA
of greenlight.guru.
• 17+ years in medical device industry
• Product development engineer, greenlight.guru produces beautifully simple
quality, design control and risk management
quality manager, regulatory
software exclusively for medical device
specialist
manufacturers. We help you bring higher
• 40+ products to market
quality devices to market faster and with less
• Expert at QMS implementations
risk.
• Dozens of ISO audits & FDA
inspections http://greenlight.guru
@creoquality @greenlightguru
Jon.Speer@greenlight.guru
+1 317 960 4280
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
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
Design Controls
An introduction
1997.
21 CFR 820.30.
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.

User Needs & Design Input
The FDA differentiates between
user needs and technical requirements
820.30 Design Controls Design Planning
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.
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
“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.
820.30 Design Controls Design Inputs
Design inputs need to be organized and

differentiated between users, customers and
stakeholders. Design inputs must be clear and
verifiable.
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
“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
User Needs
Marketing
Needs
“Concept” Documents per FDA
Customer
Guidance 1997 Design Controls
Needs
Other
Stakeholder
Needs
User Needs Am I ever going to tell you

that I need a catheter
Marketing with a tensile strength of
Needs 10 +/-‐ 2 N?
Customer
Needs
Other
Stakeholder
Needs
User Needs
Marketing • Solution independent

Needs
Product • Clear
Customer
Requirements • Concise
Needs • Verifiable
Other
Stakeholder
Needs
User Needs
Marketing WHAT? HOW!

Needs
Product
Specifications
Requirements
Customer
Needs
Other
Stakeholder
Needs
User Need Design Input Design Output

(Requirement) (Requirement) (Specification)
The catheter shall

The catheter shall have a torque ratio Material specifications
be easy to
of 1:1
manipulate.
Test methods
Drawings
Design Input This may involve iterative
(Requirement)
testing until the design input
requirement is determined.
The catheter shall • TBD in initial drafts of DI
have a torque ratio
of 1:1
documents are acceptable –
help guide feasibility testing!
• May shift over time
• Impact assessment
“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?
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

“Device shall be portable”….


“Device shall be compliant to ISO 10993-‐1…”


Device shall be formed into a 50 mm

Device shall be flexible VS 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.
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?
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
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”
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?”)
The importance of traceability.

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.”
Risk Management
An overview
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.
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
ISO 14971 Risk Management Key Terms
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
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

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 Process Overview
ISO 14971 Risk Management Establish Framework
ISO 14971 Risk Management Risk Analysis
ISO 14971 Risk Management Risk Analysis
Include end-‐users as part of the

process.
Hazards I can be a valuable

resource throughout the
Foreseeable Risk Management
Sequence of Process!
Events
Hazardous
Situations
Harms
ISO 14971 Risk Management Risk Evaluation
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.
ISO 14971 Risk Management Risk Assessment
ISO 14971 Risk Management Risk Assessment
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.
My Design Outputs,
Design Verifications,
and Design Validations
can be used as Risk
Control Measures.
ISO 14971 Risk Management Risk Acceptability
ISO 14971 Risk Management Risk Acceptability
Medical benefits of the medical

device need to outweigh the risks to
patients and end-‐users.
Have me help you

with risk / benefit
analysis of your
product.
ISO 14971 Risk Management Risk Management Report
ISO 14971 Risk Management Production / Post-‐Production
Design Review
An overview
820.30 Design Controls Design Review
Design reviews shall be planned and conducted

at appropriate stages during medical device
product development.
“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.”
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.
Design History File
What goes in DHF?
820.30 Design Controls Design History File (DHF)
DHF contains documented evidence that

medical device was developed according to
established design plan.
DHF contains all design controls.
“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.”
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”.
It is my responsibility

to document design
controls and maintain
the DHF.
Q&A
Part 1
Getting in Touch
David Amor Jon Speer

@medgineering @creoquality @greenlightguru
david@medgineering.com Jon.Speer@greenlight.guru
786.546.1806 +1 317 960 4280
Quality Management Software
www.21cfr820.com
Exclusively for Med Devices
www.myquickconsult.com
http://greenlight.guru
The Complete Guide to
FDA Design Controls
Part 2
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
Design Outputs & DMR
Design Outputs – more than just drawings!
820.30 Design Controls Design Outputs
Design outputs aren’t just specifications and

drawings.
What can I show you in my books to

demonstrate that the design inputs are being
met/ fulfilled/ satisfied – how can I prove it?
• “Establish and maintain procedures for

documenting design output in terms that
allow an adequate evaluation of
conformance to design input requirements”
• 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.”
• “Design output procedures shall contain or

make reference to acceptance criteria….”
• 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!
• “and shall ensure that those design outputs

that are essential for the proper functioning
of the device are identified.”
• PLAIN ENGLISH: ‘Essential for proper

functioning’ means you should know the
Intended Use and what design aspects are
most critical to meet it.
Design outputs: format

and type
Material Inspection Service

Drawings
Specification reports. instructions.
Mfg Batch Testing Software

Instructions Records instructions. code.
QA specs/ Packaging/ Risk Mgmt

Test results.
procedures. Labeling. File

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?
”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?
The total finished design output consists of the

device, its packaging and labeling, and the
device master record.
The DMR is the “one stop shop” for design

outputs, often maintained in a DMR Index.
Design Verification &
Design Validation
An overview
820.30 Design Controls Design Verification
Design Input Design Output

Design Verification
(Requirement) (Specification)
Did I design my

medical device
correctly?
820.30 Design Controls Design Validation
User Needs Medical Device Design Validation
Did you design the

correct medical
device?
“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.”
“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. ”
Design Verification demonstrates that the

medical device Design Outputs meet the Design
Inputs.
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

Design Verification
The catheter shall Material specifications Plans

have a torque ratio
of 1:1
Drawings Methods
Results
Design Verification Methods
Testing
Design Verification
Inspection
Plan
Analysis
• Design Inputs must be clear

• 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.
Design Verification Methods
Testing
Design Verification
Inspection Results
Plan
Analysis

Design Verification
Did I design my

medical device
correctly?
Design Validation demonstrates that the

medical device meets the needs of the end-‐
user(s).
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
• “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.
The catheter shall Plans

be easy to
manipulate.
Methods
Results
Design Validation Methods
TESTING!!
Design Validation
Inspection
Plan
Analysis
• Design Inputs must be clear

• 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.
Design Validation Methods
TESTING!!
Design Validation
Inspection Results
Plan
Analysis
Did you design the

correct medical
device?
Design Transfer
Not an event – but a process!
820.30 Design Controls Design Transfer
Design transfer is the translation of all of the

design work to the production and testing
processes that will make it commercial-‐izable.
Design Transfer Myths
• 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.
Source of Misconceptions
21 CFR Part 820.30 Design Control
b) Design & Development Planning Which gets visualized as:
c) Design Input
d) Design Output
e) Design R eview Planning
Design Design Design Design Design Design
f) Design Verification Input Output Review Verification Validation Transfer
g) Design Validation
h) Design Transfer
i) Design Changes
But the p rocess really looks more like this:

Design & Development Planning
Design Input
Design Output
Design Review
Design V erification
Design V alidation
Design Transfer
Design Transfer Completion
• All Device Master Record (DMR) elements reviewed, • All equipment identified and calibrated and
approved, and production r eleased maintenance procedures are in place
• All (DMR) elements are managed under formal • Manufacturing personnel and inspectors have been
change control trained
• Risk assessments completed and all identified risks • All supplier agreements and qualifications are
appropriately dispositioned complete
• Defined and implemented test strategy for incoming, • Procedures in place to ensure control of device
in-‐process, and final acceptance testing handling, storage and distribution of product
• Plans in place to monitor and/or control features • Procedures in place to ensure identification and
identified as critical to quality traceability of product
• Process validation complete • Design verification testing performed and

demonstrates design outputs meet design inputs
• Test methods validated and complete
• Design validation testing performed demonstrates
design meets user needs & intended uses
• Inspection procedures, visual inspections, and
workmanship standards are complete
• All elements of the Design Transfer Plan have been
completed or otherwise addressed
• Installation and servicing procedures are complete
“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.”
Discussion Point: a process should identify what represents

“accurate translation” of the device design.
Regulatory Submissions
The DHF forms the basis for your objective evidence
that the device has been designed to be
safe and effective
United States
DOJ enforcement
Who are the regulators?
European Union
• Classified according to risk and
“criticality” to patient/ end-‐user
US Device • (3) letter code groupings with names
Classifications and attributes
21 CFR 860 • 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.
Class I Class II Class III
not intended to help more critical than Class I support or sustain human
support or sustain life or be but designed to perform as life, are of substantial
substantially important in indicated without causing importance in preventing
preventing impairment to injury or harm to patient or impairment of human
human health, and may not user. health, or present a
present an unreasonable potential, unreasonable risk
risk of illness or injury of illness or injury
LOW RISK MEDIUM RISK HIGH RISK
General Controls General Controls + General Controls

Special Controls + Premarket Approval
510(k) (PMA)
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
Class I Class II Class III
General controls + 510(k) or PMA
Submitting a depending on risk and intended use
of device
Medical Device in
United States Implement a quality management
system
Why do I need to comply to ISO 13485?
Registration &
21 CFR 820 (QSR) Submission
The 2 main pathways of getting to US market.
Pre-‐market Pre-‐market
notification approval (PMA)
The 510(k) – Substantial Equivalence
Substantial
Equivalence = Intended Use & Technological
Characteristics
Different
Technological
+
Characteristics
or
No new safety or
efficacy concerns
Pre-‐market
Traditional
notification
Special (20%)
Abbreviated (5%)
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.
510(k) Data
http://www.emergogroup.com/resources/research/fda-‐510k-‐review-‐times-‐research
The SE Letter.
Q&A
Part 2
Getting in Touch
David Amor Jon Speer

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

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The Complete Guide to

FDA Design Controls

April 26th, 2016

Investigational Device Exemption (IDE) – 21 CFR 812.

Use a development plan. Keep it short and

The extent of design and

• Refining is OK – especially for new

Discussion Point: Lack of documented planning shows poor oversight

Design inputs need to be organized and

Design requirements are the single

“There’s never time to do it right but

“Drilling down” inputs is critical.

• Refining is OK – especially for new

“Drilling down” inputs is critical.

“Drilling down” inputs is critical.

User Needs Am I ever going to tell you

“Drilling down” inputs is critical.

Marketing • Solution independent

“Drilling down” inputs is critical.

Marketing WHAT? HOW!

User Need Design Input Design Output

The catheter shall

“Failure to establish and maintain

Discussion Point: When you create a user needs / requirement

Design Inputs must be clear

• If basing design inputs on a standard,

Design Inputs must be clear

“Device shall be portable”….

Design Inputs must be clear

“Device shall be compliant to ISO 10993-­‐1…”

Design Inputs must be clear

Device shall be formed into a 50 mm

• Functional: what does the device do?

A note on drafting requirements.

A note on drafting requirements.

Don’t stress about documenting

• FDA distinguishes between R&D and

“Failure to establish and maintain

Intended Use is important for

Risk Management & Design Controls

Product Risk Management is a

• Start Risk Management process early

RISK MANAGEMENT -­‐ systematic application of management

HAZARD -­‐ potential source of harm

HAZARDOUS SITUATION -­‐ circumstance in which people,

SEVERITY -­‐ measure of the possible consequences of a hazard

Include end-­‐users as part of the

Hazards I can be a valuable

Risk Evaluation criteria shall be

• Use sources like MAUDE and other

Risk Controls are means to

Priority of Risk Control options:

Medical benefits of the medical

Have me help you

Design reviews shall be planned and conducted

“Failure to document the design review results, including

Timing of design reviews is a

• All design controls need to be part of

DHF contains documented evidence that

“Failure to establish and maintain a design

If it isn’t documented, then it didn’t

• Establish a DHF per product.

It is my responsibility

“Device shall be compliant to ISO 10993-‐1…”

RISK MANAGEMENT -‐ systematic application of management

HAZARD -‐ potential source of harm

HAZARDOUS SITUATION -‐ circumstance in which people,

SEVERITY -‐ measure of the possible consequences of a hazard

Include end-‐users as part of the