Design Requirements Training

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Design Requirements
& Analysis

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Pre-requisites & Ground Rules
 Pre-requisites:
Design Control Training
Bring draft of Requirement Documents
Provide Sources of inputs to generate
Requirements
 Ground Rules:
Share work with other teams
Team learning experience

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Topic Time
(min)
Takeaways
Introduction 10
Role of Requirements 30  Why have good requirements?
 Benefits of having good requirements
Sources & Tools for
gathering requirements
20  Sources of requirements
 Tools for requirements gathering
Characteristics of a
Quality Requirement
Statement
30  Common Characteristics of a Good Quality Requirement
Statement
 How to check for a good requirement
 Critic requirements examples
Design Control
Architecture - PCD
60  Understanding the PCD - Characteristics & Examples
 Application through team exercise
Lunch & Breaks 60
Design Control
Architecture - SRD
90  Understanding the SRD - Characteristics & Examples
Design Control
Architecture - SSRD
90  Understanding the SSRD - Characteristics & Examples
Design Requirements & Analysis
Training

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Medical
Device
Design
Validation
Planning
Verification & Validation
Design
Verification
Customer
Requirements (PCD)
System &
Subsystem
Requirements
Design &
Development
Design
Output
DI/DO/DTM as part of PDP
Design Trace
Matrix

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Design Requirements as part of PDP
Design &
Development
Phase
• D&D Plan
• DI Documents
• RAMT
• DTM
DI & Planning
Review
Development
Phase
Proceed
Stopped
Revise
Planning Phase
Core Team
Formed
Team Training & Activities:
•Planning
•Design Input
•Risk Management
•Design Traceability

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Design Requirements & Analysis
Role of
Requirements
Sources & Tools
of Requirements
Gathering
Characteristics of Quality
Requirement Statement
Design Control Architecture:
PCD, SRD & SSRD

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Why Requirements Definition is important?
Compliance Automation Inc.

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The Role of Requirements
‘Who are those guys, anyways?’
 A statement(s) of what user capabilities
or services a system or product needs to
deliver
Operational need translated into
descriptions, physical and performance
parameter
Objective, complete, clear, testable

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Why do Specifications Matter?
 Are they ‘just another deliverable’?
 What is influenced by requirements?
 What role do requirements play in
development efficiency?
 What is the regulatory impact with respect to
requirements?

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Advantages of Developing Excellent Requirements
 Customer - Understand customer needs,
desired outcomes and product intended use
 Team – On the same page, pulling in the
same direction, common ownership
 Planning - Defines the scope and complexity
of an effort
 Team members – know what is expected,
sets up successful outcomes
 Business – communicate, plan and deliver
results

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Consequences of Poor Requirements
 Lack of a cohesive team effort
 Inability to launch a product
 Late projects, sliding schedules
 Cancellation at phase gate review
 Unsuccessful or unacceptable products
or services

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Cost Pyramid
Requirements
Architecture
Detailed Design
Manufacturing
Verification
Field Action

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A Case Study
 Incomplete requirement set on diagnostic device
regarding priority of error reporting
3 stated requirements
1. Requirement for reading > 500 reported as ‘high’ result
2. Error trap requirement for insufficient blood (X < 0.006)
3. Error trap requirement for blood on wrong side of strip (X > 0.09)
Missing requirement
• Priority of combined errors (1 and requirement 2 or 3)
 Design assumption made
Incomplete or inaccurate requirement analysis
 Verification successful
 Validation does not show issue (low occurrence)

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A Case Study (Cont)
 Severe Action Taken
• Field action required – recall
• Agency investigations
• Litigation
• Probation and penalties
 Potential danger to customers
 Lost opportunities
 Direct financial loss
 Potential danger to customers
 Lost opportunities
 Direct financial loss

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 Understand the user need and intended use as the
basis for design and development:
Without understanding the customer requirements (e.g. user needs,
intended uses), what are the reasons for design and development?
 Provide an accurate translation of customer need
and intended use to minimize design
redundancies:
Planning, design decisions and project execution can be done
efficiently.
Reduces the probability that errors will be introduced through
redesign or design omissions

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 Create the foundation for product design and
development – Product requirements are the cornerstone in
providing results
 Product Development Process:
 Cycle time reduction
 Product quality fulfilling customer need and desired outcomes
 Reduce or eliminate recalls and field actions
 Increase NP revenues
 Design (product and process) improvements:
 Quality product
 Process and performance stability

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 Complete definition and management of labeling
claims:
 The Marketing Team will have the competitive advantage in providing
the product features to the customers.
 Availability of information to suppliers for product changes.
 Better control of the product development
process:
 The development team will be able the manage the project through
prioritization.
 Focus on the essential requirements of the product that will delight
the customer.

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 Improved quality and end-user satisfaction :
 Product benefits consistent with customer desires
 Consistent performance
 Improved, predictable reliability
 Improves Team Communication:
 Minimizes guess work, interpretation and disconnects
 Brings team to the same level of understanding

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 Easier compliance with regulations through
objective evident:
 Documented Design Verification and Validation Activities
 Traceability
 Reduces Rework/Redesign/Add Product Features:
 More efforts can be focus adding Product Features that will delight
the customers.
 Improving the reliability and the quality of the products
 Gain Market Share:
 Speed to market
 Product cycle time reduction

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What’s wrong with this picture?

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Sources of Requirements
 Input Sources to Marketing
Requirement Document
Business
Proposal
• Regulatory Requirements
• J&J Business Requirements
• Customer input
• Technology Assessment
Marketing
Requirement
Document

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• Operations
• Product Support Teams
• CAPA
Marketing
Requirement
Document
PHA and Preliminary
Human Factors
Analysis
Product Criteria
Document
 Customer - Input Sources for the PCD
Additional Input Sources:
 Regulatory & Statutory
LifeScan Business Requirements
Others
Sources of Requirements

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System
Requirements
Document
Sub-system
Requirements
Documents
Product Criteria
Document
Additional Hazards
and Human Factors
Analysis
Design FMEA
and Fault Tree
Analysis
 Product - Input Sources for the SRD & SSRD
Sources of Requirements (cont.)Sources of Requirements (cont.)

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 Product – Other Input Sources for the SRD &
SSRD
Marketing
Competitive Benchmarking
Legacy Requirements
Internal Benchmarking
Brainstorming
Complaints
Technical Services Group
CAPA
Other Sources
Sources of Requirements (cont.)

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Tool for Gathering Requirements
Ishikawa Fishbone (cause-and-effect) Diagram
SMBG System
Electronics
Requirements
Labeling
Requirements
Mechanical
Requirements
Software
Requirements
Strip & Reagent
Requirements
Other
Requirements

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 Advantages of cause-and-effect diagram
Identify sources of requirements
Apply to all levels
Focus on specific issue without resorting to complaints and
irrelevancy
Easy to use
 Disadvantages:
Relationship not well define
Interrelationships not defined

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Quality Function Deployment (QFD)
Relationship
Customer to System
Customer(PCD)
System
Priority
Importance
System to Subsystems
Relationship
Subsystems
Importance
Priority
System

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 Advantages of QFD
Clear translation of customer requirements into design through logical
steps
Robust and applicable to projects of varying size, scope, and
complexity
Allows user to prioritize and focus on the elements that are critical to
quality (CTQ)
Able to define complex inter-relationship
Provides the platform for post launch design change control by
depicting trace through entire system
Forces requirements to be analyzed for ambiguity and redundancy
Analysis for V&V planning done with requirements definition
 Disadvantages of QFD:
Requires substantial up front investment
Requires specialized training

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What wrong with this picture?

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Characteristics & How to Check for Goodness
Characteristics that Individual Requirement Statement
Should Exhibit:
 Necessary
 Concise
 Implementation Free
 Attainable
 Complete
 Consistent
 Unambiguous
 Verifiable
 Correct
 Feasible
 Prioritized

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 Necessary - The stated requirement is an essential capability, physical
characteristic, or quality factor of the product or process. If it is removed or
deleted, a deficiency will exist, which cannot be fulfilled by other
capabilities of the product or process.
One good test of necessity is traceability
Traceable - You should be able to link each requirement to its source, which could
be a higher-level system requirement, risk mitigation, a use case, or a voice-of-the-
customer statement. Also link each requirement to the design elements, source
code, and test cases that are constructed to implement and verify the requirement.
Traceable requirements are uniquely labeled and are written in a structured, fine-
grained way, as opposed to large, narrative paragraphs or bullet lists.
 Concise (minimal, understandable) - The requirement statement
includes only one requirement stating what must be done and only what
must be done, stated simply and clearly. It is easy to read and understand.

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 Implementation free - The requirement states what is required, not how
the requirement should be met. A requirement statement should not reflect
a design or implementation nor should it describe an operation.
At the system level, requirements can be truly abstract or implementation free. An
example of a requirement for a monitor system at the system level is: "The system
shall be capable of detecting a power failure.” This sentence should be followed by
expected performance data (a quantification of what "detecting" means) against
specific power failures. When no specific implementation has been stated, the
system designer is free to pursue alternative, competing system designs.

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 Attainable (achievable or feasible) - The stated requirement can be
achieved by one or more developed system concepts at a definable cost.
This implies that at least a high level conceptual design has been
completed and cost tradeoff studies have been conducted.
 Complete (standalone) - The stated requirement is complete and does
not need further amplification. The stated requirement will provide sufficient
capability.
 Consistent - The stated requirement does not contradict other
requirements. It is not a duplicate of another requirement. The same term
is used for the same item in all requirements.
 Unambiguous - Each requirement must have one and only one
interpretation. Language used in the statement must not leave a doubt in
the reader's mind as to the intended descriptive or numeric value.

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 Verifiable - The stated requirement is not vague or general but is
quantified in a manner that can be verified by one of these 4 alternative
methods: inspection, analysis, demonstration or test.
Determine how the requirement will be verified.
Alarm example:
Within a system, both visual and audible alarms are often required to warn
the user about abnormal or unsafe conditions. Also, the same alarm is
used for multiple conditions, such as system failure, strip insertion, test
results and low batteries.
To verify that both the visual and audible alarms work together, all tests
must include both. Therefore, the visual and audible parts should be
combined into a single requirement. Further, if the conditions providing
inputs to the alarm can be incorporated into the same test or
demonstration, these should also be included in the same requirement.
An example of a requirement following this approach can be "The element
shall provide a visual and audible alarm under all conditions listed in Table
3-10. The alarm shall be activated no longer than 1 second after the
condition exists."

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 Correct - Each requirement must accurately describe the functionality to
be delivered. The reference for correctness is the source of the
requirement, such as an actual customer or a higher-level system
requirements specification. A software requirement that conflicts with a
corresponding system requirement is not correct (of course, the system
specification could itself be incorrect).
Only user representatives can determine the correctness of user
requirements, which is why it is essential to include them, or their close
surrogates, in inspections of the requirements. Requirements inspections
that do not involve users can lead to developers saying, "That doesn’t
make sense. This is probably what they meant." This is also known as
"guessing."

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 Feasible - It must be possible to implement each requirement within the
known capabilities and limitations of the system and its environment.
To avoid infeasible requirements, have a developer work with the
requirements analysts or marketing personnel throughout the elicitation
process. This developer can provide a reality check on what can and
cannot be done technically, and what can be done only at excessive cost
or with other tradeoffs.

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 Prioritized - Assign an implementation priority to each requirement,
feature, or use case to indicate how essential it is to include it in a
particular product release. Customers or their surrogates have the
lion’s share of the responsibility for establishing priorities. If all the
requirements are regarded as equally important, the project manager
is less able to react to new requirements added during development,
budget cuts, schedule overruns, or the departure of a team member.
Priority is a function of the value provided to the customer, the relative
cost of implementation, and the relative technical risk associated with
implementation.
Three levels of priority:
High priority means the requirement must be incorporated in the next
product release.
Medium priority means the requirement is necessary but it can be
deferred to a later release if necessary.
Low priority means it would be nice to have, but we realize it might
have to be dropped if we have insufficient time or resources.

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Characteristics of Quality Requirements
Other Characteristics of a good Requirement
 Unique – A requirement should have a unique label, a unique name and
unique contents.
 Documented and Accessible – A requirement must be documented
(e.g. writing, pictures, images, database, etc.) and the documentation
must be accessible.
 Identifies Applicable States – Some requirements only apply when the
system is in a certain states or modes. If the requirement is only to be
met sometimes, the requirement should reflect when.
For example: The vehicle shall:
 Be able to tow 2000-pound cargo trailer at high way speed (65 MPH)
 Accelerate from 0-60 MPH in less than 10 seconds

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Requirement Fundamentals
Some words to avoid for the SRD and SSRD:
Vague and general words be avoided. Avoid "flexible", "fault tolerant", "high
fidelity", "adaptable", "rapid or fast", "adequate", "user friendly", "support",
"maximize" and "minimize“.
For example: "The system design shall be flexible and fault tolerant".
Other words that should be avoided are "and/or", "etc." and "may".

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Here are some examples of problematic
requirements:
Original: "The product shall switch between displaying and hiding
nonprinting characters instantaneously."
Not feasible: Computers cannot do anything "instantaneously".
Incomplete: Does not state under what conditions the switching
occurs. Does it happen automatically, or as a result of user
input?
Ambiguous: What does "nonprinting characters" mean? Hidden
text? Attribute tags? Control characters?
Rewritten: "The user shall be able to toggle between displaying and
hiding all HTML markup tags in the document being edited
with the activation of a specific triggering mechanism."

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Problematic Requirements (cont.):
Original: "The software shall be able to clear the monitor after a
successful upload."
Incomplete: Under what conditions is the monitor cleared? All
the time? Or is a specific action required?
Ambiguous: What does "clear the monitor" mean?
Rewritten: "After a successful upload from the monitor, the software
shall query the user as to whether s/he wants to erase the
uploaded test records from the monitor's database."

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Problematic Requirements (cont.):
Original: "The monitor shall be able to store up to 1500 test records."
Ambiguous: Does this mean that if the monitor can store more
than 1500 records it is in violation of this requirement? Does it
mean that if it can only store 1100 records that is okay ?
Rewritten: "The monitor shall be able to store at least 1500 test
records."

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Before & After Examples
Original: "The monitor’s push buttons may be used for optional
settings."
Ambiguous: What does “may” mean?
Rewritten: "Optional settings shall be accessible through the monitor’s
buttons.“
Original: "The monitor should store test results and errors. Test results
include INR result, date, time, and system quality control
results."
Ambiguous: Should?
More than one requirements?
Verifiable: How many test results?
Rewritten: "The Monitor shall provide storage for a minimum of 75 test results.“
“Stored test results shall include the date and time stamp, an INR
result from 0.8 to 8.0 if testing passes, ‘HI INR’ for high results, ‘LO
INR” for low results if a result is reported, or an error code if testing
fails. Stored results also include Control 1 and Control 2 values.“

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Original: "Test strip can hold sufficient sample without overflowing."
Attainable: How much is sufficient?
Rewritten: "The test strip shall accommodate a variety of sample sizes
(20 to 40 micro liter) without the sample overflowing beyond
the sample application area.“
Original: "The monitor retains test result memory and additional
memory without batteries."
Ambiguous: What additional memory?
Rewritten: "The monitor shall store test results, calibration coefficients,
algorithm coefficients, and test strip lot-specific calibration
data (calibration codes) in non-volatile memory."

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Original: "At a rate of one (1) test per week, the monitor indicates a low
battery condition with at least four (4) tests remaining."
Unclear: How does rate relate to indicator for low battery
condition?
Rewritten: "The monitor shall indicate a low battery condition with
enough remaining power for at least four tests.“
Original: "The test strip prevents direct contact between the operator
and any of the test strip reagents."
Consistent Wording: Use “shall”. Operator is referred to as
“user”.
Rewritten: "The test strip shall prevent direct contact between the user
and any of the test strip reagents."

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Design Control Architecture
PCD Product Criteria
Document
SRD
System Requirement
Document
SRS RRSMRS ERS
Subsystem Requirement Documents (SSRD)
LRSPRS

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Design Control Architecture – PCD
Characteristics:
 User/Customer Needs
A review of the Customer’s needs based upon Market Research and
Focus Groups.
 Intended Use
A review of the claims that will be included in the labeling defining how
the device will be used and who the primary end users will be. This
could also include hospital guidance and interface requirements with
other devices.

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Characteristics:
 Regulatory and Statutory
The domestic and international requirements for the device based upon
the intended market, including any regional standards, directives, laws,
and regulations.
 Business Needs
Specific Requirements mandatory for product acceptability (e.g. COGS,
Quality, Reliability, etc.).
 Others
Design for Manufacturability
Testability
Customer Service

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 User Needs
monitor Criteria
Examples The monitor shall be easy to turn on an off.
Button functions shall be easy to understand and use.
The monitor shall automatically turn itself off after a period of
inactivity to conserve battery power.
monitor display shall be easy to read and visible in normal lighting
conditions.
The monitor surface shall be easy to clean and sanitize.
Test Strip Criteria
Examples The user shall be able to insert the test strip in the monitor easily.
The test strip handle area shall be clearly marked.
The sample size from a single finger stick shall be sufficient to
give an accurate test.
The product shall provide accurate results over the stated life of
the product if kept in its original packaging.

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 Intended Uses
Examples The product is intended for use by health care professionals at
the point of care.
The product is intended for use by laypersons in the home for
patient self-testing.
The product shall be used for quantitative measurement of PT in
fresh capillary blood as an aid in monitoring oral anticoagulation
(Warfarin) therapy.
The product shall be used for quantitative measurement of PT in
venous whole blood as an aid in monitoring oral anticoagulation
(Warfarin) therapy.

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 Regulatory and Statutory Requirements
Certification Criteria
Examples The product shall meet CAN/CSA C22.2 No. 601.1, Medical
Electrical Equipment - Part 1: General Requirements for Safety
(equivalent to IEC 601.1) including any applicable collateral
standards.
International Electro-technical Commission (IEC), IEC601-1-4,
Safety Requirements for Programmable Electronic Medical
Devices shall be followed.
Labeling and Packaging Criteria
Examples Product labeling, packaging, and documentation shall be
readable and understandable.
Product packaging and labeling shall include general instructions
for how the product shall be used.

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 Others
Examples The Rubicon Monitor shall be marketed in conjunction with the
Rubicon Test Strip.
The monitor shall be storable and transportable in an acceptable
range of environmental conditions.
There shall be no user-serviceable components, except for
batteries.
Removable parts (i.e., test strip holder and batteries) shall be
field-replaceable.
Replacement parts shall be compatible with all monitors.

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 Team Exercise

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Design Control Architecture – SRD
Characteristics:
 Functional
Functional requirements specify what the design does. Focus is on the
operational capabilities, the processing of inputs and the resulting outputs.
 Physical & Performance
Physical and Performance requirements specify how much or how well the
design must perform, addressing such issues as speed, strength, size,
weight, response times, accuracy and precision, limits of operation, etc.
 Interface
Interface requirements specify characteristics that are critical to compatibility
with external systems (including user and/or patient interface, if applicable).
 Others

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 Functional
QC Requirements
Example The monitor shall have the capability of detecting a power failure
and shall not display or store result from a test that is in-progress.
System Requirements
Example The system shall produce a test temperature at the assay site of
39 +/- 1 C.⁰
The system shall complete the test and display an INR result or
an error message, with time and date stamp, within 2 minutes of
sample application
Monitor Requirements
Example Batteries inserted incorrectly (wrong polarity) shall not damage
the monitor.
The Monitor shall turn itself off to conserve battery power after at
least 90 seconds of being idle while waiting for user action.

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 Physical and Performance Requirements
monitor Requirements
Example The monitor dimensions shall be no greater than 8.0” long x 3.4”
wide x 2.2” high (20.3 cm long x 8.6 cm wide x 5.6 cm high).
Test Strip Requirements
Example The test strip dimensions shall allow easy insertion of the test
strip to be into the test strip holder.
System Requirements
Example The system shall provide accurate results for a temperature
range of 15 to 35° C.

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 Interface Requirements
Monitor Requirements
Examples The monitor shall prompt the user to confirm or reset the
CalCode.
The monitor shall alert the user if the test strip is inserted
incorrectly.
Test Strip Requirements
Examples The test strip shall be clearly marked as to the orientation and
direction of insertion.
The test strip shall prevent direct contact between the user and
any of the test strip reagents.
Labeling Requirements
Examples Product labeling shall conform to 21CFR820 part 809.10.
Product labeling shall conform to CAN/CSA C22.2 No 601.1.
Product labeling shall contain instructions for the user to properly
and safely operate the system.

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 Team Exercise

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Design Control Architecture – SSRD
 Functional
 Interface
 General Design Goals & Constraints
SRS RRSMRS ERS
Subsystem Requirement Documents (SSRD)
LRSPRS

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Characteristics:
 Functional
Functional requirements specify what the design does. Focus is on the
operational capabilities, the processing of inputs and the resulting outputs.
Physical and Performance requirements specify how much or how well the
design must perform, addressing such issues as speed, strength, size,
weight, response times, accuracy and precision, limits of operation, etc.
 Interface
Interface requirements specify characteristics that are critical to compatibility
with external systems (including other Subsystem and user and/or patient
interface, if applicable).
 General Design Goals & Constraints

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Software Design Constraints
 General Design Constraints
Regulatory Policies
Hardware Limitations (e.g. time requirements)
Interfaces to Other Applications
Parallel Operation
Audit Functions
Control Functions
Higher-Order Language Requirements
Handshake Protocols
Critical Nature of Application
Safety and Security Considerations

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Software Design Constraints
 General Design Constraints
Hardware
Software
Serial Communication

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Software
 Functional Requirements
The essential functions provided by the software product. These
requirements detail the behavior of the software. They should be
grouped according to the product functions specified in the Product
Function Overview. Sections may include; General Functions, Power-
On and Self-Test, Serial Command Processing, Configuration of
monitor Options, Performing a Glucose Test, and Reviewing Stored
Data. Each section should contain those requirements associated with
that particular function.

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Software
General Functions
Power-On and Self Test
Serial Communications
Serial Command Processing
monitor Configuration
Data Storage
Test Mode
Calibration Strip Mode
Setup Mode
Data Review Mode
User Data Management Mode
Mimic Mode
Functional Tests

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Software
 User Interface Requirements
Describe aspects of the part of the software that interfaces the
user to the monitor or application. This might include response
time for button presses, debouncing requirements, minimum
font size restrictions, standard error message formats, standard
objects that must appear on every screen, etc. Do not include
screen images or other design information in this section
unless they truly represent a required feature.

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Software
 External Interface Requirements
External interfaces can include interfaces to hardware
components of the system (displays, buttons, sensors, valves,
etc), software components of the system (databases, drivers,
etc.), or external devices (via serial port or network
connection).

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Software
 Performance Interface Requirements
Describe the numerical requirements placed on the software or user
interaction with the software. Only measurable performance
parameter shall be specified (file size, response time, frequency,
etc.). Performance requirements for a particular function should be
specified in the appropriate “Functional Requirement” section.

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Electronics
 General Design Goals and Constraints
Electronic Components
Size
Weight
Yield
Cost
Testability

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Electronics
Mechanical
Strip & Reagent
Software

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Electronics
monitor Measurement Requirements
CALCODE Setting and Input
Power Supply Generation & Distribution
System Architecture
• Test Result and Calibration Memory (e.g RAM)
• Processors
• ASIC
Buttons
Audio
Communication Interface
Battery Requirements
• Life
• Installation
Real Time Clock
System Fault Requirements
• Detection
• Reporting

71
Electronics
Sample Application Detection
Strip-In-Place Detection
Assay Detection
Reagent Temperature Control
• Heater Driver
• Heater Sensor Amplifier

72
Electronics
Electromagnetic Compatibility
• Electrostatic Discharge
• Electromagnetic Immunity
• Electromagnetic Emissions
Accuracy & Precision
• Drift Voltage
• Reference voltage
• Frequency
• System Timing Accuracy
• Resolution of ADC

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Electronics
 Durability & Reliability Requirements
MTTF & MTBF
Operating Environmental Conditions
• Temperature
• Humidity
• Altitude
Non-Operating Environmental Conditions
• Storage
• Shock

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Mechanical
Mechanical Components
Size
Weight
Yield
Cost
Testability

75
Mechanical
Electrical
Strip & Reagent
• Test Strip Insertion
• Test Strip Support
• Strip Holder
Software

76
Mechanical
System Fault Requirements
• Detection
• Reporting
Sample Application Sensor
• Sample Detection
Assay Optics
• Optical System
Strip in Place Detection
• Test Strip Detection
Reagent Temperature Control
• Test Strip Temperature
• Blood Sample Temperature
Battery Requirements
• Battery Type
• Battery Life
• Installation

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Mechanical
 Functional Requirements (cont.)
Monitor Assembly
• Temperatures
• Alternative Power Source
• Cleaning
• Display
• Graphics
• Ergonomic
• Safety
• Identifier
Buttons
• Requirements
• Interface
Communication Interface
• Data/Serial Communications Port
• Power Port
• Data Port Recognition

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Mechanical
Sample Application Sensor
• Wavelength
• Window Transmission Percentage
Heater
• Temperature
• Sensor
Monitor
• Label Area
• Shipping
• Storage
• Shock Hazard
• Fire Hazard
• Size
• Weight
Electromagnetic Compatibility
• ESD Emissions

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Mechanical
 Durability & Reliability Requirements
MTTF & MTBF
Operating Environmental Conditions
• Temperature
• Humidity
• Altitude
• Light
• Orientation
Non-Operating Environmental Conditions
• Storage
• Shock
• Rigidity
• Impact
• Vibration
• Fluid Intrusion
• Cleaning & Chemical Resistance

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Strip & Reagent
Size
Yield
Cost
Testability

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Strip & Reagent
QC Requirements
CalCode Requirements
PT Reagent

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Test Strip and Strip-in-Place Dimensions
Cleanliness
Thermal Characteristics
Fluidic Characteristics (e.g Flow Channel)
Physical Attributes (e.g. Clarity)
Precision & Accuracy
Stability
Shipping
Strip & Reagent

83
Mechanical Characteristics
Electrical Characteristics
Software
Strip Handling
Strip & Reagent

84
Labeling
 Labeling on the monitor
User Needs
Example: All monitor labeling shall be clearly legible.
Regulatory/Statutory
Example: The monitor label shall specify “For In Vitro Diagnostic Use”.
LifeScan Labeling Requirements
Example: The monitor label shall include a LifeScan copyright symbol.
 Owner’s Booklet
User Needs
Example: The Owner’s Booklet shall contain instructions for the user to
properly and safely operate all components of the system.
Example: The Owner’s Booklet shall include all applicable equipment
classifications from CAN/CSA 601.1-M90 Clause 5.
Example: The Owner’s Booklet shall include an artwork number.

85
Labeling
 Logbook
User Needs
Example: The logbook shall provide space to record the result of each test.
Example: The Owner’s Booklet Addendum shall include an artwork number.
 monitor Kit Carton Labeling
User Needs
Example: The monitor carton label shall contain the LifeScan Customer
Support and Service number.
Example: The monitor carton label shall include all information appearing on
the monitor label.
Example: The monitor carton label shall contain LifeScan copyright notice.
 Labeling on the Test Strips
User Needs
Example: The test strips shall have graphics printed on the top side to aid the
user in inserting the strip with the right side up.

86
Labeling
 POC and PST Test Strip Bottle Labels
User Needs
Example: The POC and PST test strip bottle labels shall contain instructions
for proper storage.
Example: The PST test strip bottle label shall contain the “Rx Only”
designation.
Example: The POC and PST test strip bottle labels shall contain relevant
patent numbers.
 POC and PST Test Strip Carton Labeling
User Needs
Example: The POC and PST test strip carton labeling shall have the
expiration date prominently displayed.
Example: The POC and PST test strip carton labeling shall include a Lot
Number.
Example: The POC and PST test strip carton labeling shall contain a product
number and barcode.

87
Labeling
 POC and PST Test Strip Package Inserts
Intended Use
Example: The POC and PST test strip package insert shall state that the product is for
use with the monitor.
User Needs
Example: The POC and PST test strip package inserts shall provide a quick reference
to the steps for performing a test using the monitor INR Monitoring System.
Example: The POC and PST test strip package inserts shall describe physical,
biological, or chemical indications of instability or deterioration of the reagent.
Example: The POC and PST test strip package inserts shall include an artwork number.
 monitor Kit Shipping Labeling
User Needs
Example: The monitor shipper labeling shall specify the temperature and humidity
ranges for transport and storage of the monitor.
Example: The monitor shipper labeling shall contain a product number and barcode.

88
Labeling
 POC and PST Test Shipper Labeling
User Needs
Example: The test strip shipper labeling shall indicate the number of cartons
contained in the shipper.
Example: The test strip shipper labeling shall contain a part number and
barcode.
 Instructor’s Guide
Intended Use
Example: An Instructor’s Guide shall be created for use in training and
certification of PST users.
User Needs
Example: The Instructor’s Guide shall provide written and hands-on
exercises to be performed by the trainees.

89
 Team Exercise

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