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Table of Contents
Table of Contents....................................................................................................................................................1
1.0 Purpose..............................................................................................................................................................2
2.0 Scope..................................................................................................................................................................2
3.0 Definitions.........................................................................................................................................................2
3.1 Executive Management Team (EMT)....................................................................................................2
3.2 Customer.................................................................................................................................................2
3.3 Design Input...........................................................................................................................................2
3.4 Design Output.........................................................................................................................................2
3.5 Marketing Requirements Document (MRD)..........................................................................................2
3.6 Product....................................................................................................................................................2
3.7 Product Development..............................................................................................................................2
3.8 Product Development Feasibility Study (PDFS)....................................................................................2
3.9 Product Manager.....................................................................................................................................2
3.10 Quality...................................................................................................................................................3
3.11 Product Development Team (PDT)......................................................................................................3
3.12 Validation.............................................................................................................................................3
3.13 Verification...........................................................................................................................................3
4.0 Responsibilities..................................................................................................................................................3
4.1 Executive Management Team (EMT)....................................................................................................3
4.2 Product Manager.....................................................................................................................................3
4.3 Regulatory Affairs/Quality Systems Director.........................................................................................3
4.4 Product Development Team (PDT)........................................................................................................3
5.0 References and Applicable Documents.............................................................................................................3
6.0 Procedure...........................................................................................................................................................4
6.1 Determination of Input Requirements....................................................................................................4
6.2 Sources of Information for Input Requirements.....................................................................................4
6.2.1 Customer Requirements............................................................................................................4
6.2.2 Intended Use Requirements......................................................................................................5
6.2.3 System and Product Development Requirements.....................................................................5
6.3 Development of Input Requirements......................................................................................................5
6.4 Categories of Input Requirements..........................................................................................................5
6.4.1 Functional Requirements..........................................................................................................5
6.4.2 Performance Requirements.......................................................................................................6
6.4.3 Interface Requirements.............................................................................................................6
6.4.4 System and Product Development Requirements.....................................................................6
6.5 Assessment of Input Requirements........................................................................................................6
6.6 Incomplete, Ambiguous, or Conflicting Input Requirements................................................................6
6.7 Development of Input Requirements......................................................................................................6
6.8 Development of Input Requirements......................................................................................................7
6.9 Change Control.......................................................................................................................................7
6.10 Conversion of Input Requirements.......................................................................................................7
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1.0
Purpose
This procedure defines the guidelines for establishing and documenting the design input requirements
for the development of a product design.
2.0
Scope
This procedure applies to all product development programs funded and managed by [Company Name].
3.0
Definitions
3.1
3.2
Customer
Anyone purchasing, using, operating, or interfacing with a product in any manner.
3.3
Design Input
The physical and performance requirements of a product used as a basis for product design and
development.
3.4
Design Output
The results of a design effort at each design phase and at the end of the total design effort. The
finished design output is the basis for the Device Master Record. The total finished design output
consists of the product, its packaging and labeling, and the Device Master Record.
3.5
3.6
Product
Unless otherwise specified, the word product in this procedure is used in the more global sense
to refer to components, materials, structures, machines, devices, systems, processes, software, or
services.
3.7
Product Development
The systematic development process for optimizing a products time to market, cost,
performance, quality, customer satisfaction, and risk management. A product development
simultaneously integrates all product knowledge and expertise from concept, through
manufacturing and customer satisfaction, to the end of the products life.
3.8
3.9
Product Manager
The Product Manager directs the activities of the Product Development Team and the
development program in accordance with the process detailed in this procedure and bears overall
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responsibility for management of the development program. The Product Manager is the leader
of the Product Development Team and acts as liaison to the Executive Management Team. The
Executive Management Team assigns a Product Manager to a particular product development
program.
3.10 Quality
The totality of features and characteristics that bears on the ability of a product to satisfy fitnessfor-use, including safety and performance.
3.11 Product Development Team (PDT)
A cross-functional team that plans, directs, and manages a development program. It has the
authority and responsibility to carry out the development objectives of the Executive Management
Team and to advise, coordinate, and integrate the activities of the Task Teams. The Executive
Management Team is responsible for forming the Product Development Team.
3.12 Validation
Confirmation by examination and provision of objective evidence that the particular requirements
for a specific intended use can be consistently fulfilled.
3.13 Verification
Confirmation by examination and provision of objective evidence that specified requirements has
been fulfilled.
4.0
5.0
Responsibilities
This procedure is intended as a guide. Depending on the complexity of the product and the extent of
the design requirements, the Product Manager and the PDT may not exactly follow this procedure, but
must still apply the essential elements of effective and systematic development of design input
requirements.
4.1
4.2
Product Manager
The Product Manager bears overall responsibility for successful management of the development
program and is responsible for leading and facilitating the efforts of the Product Development
Team. As the leader of the Product Development Team, the Product Manager is responsible for
coordinating and integrating their activities and acting as liaison with the Executive
Management Team.
4.3
4.4
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Kimberly
Trautman, ASQ Quality Press
The Product Development Cycle
6.0
Procedure
6.1
6.2
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Customer Requirements
Diagnostic requirements
Therapeutic requirements
Clinical effectiveness requirements
User expectations
Labeling requirements including operator guidance
Human factors
Safety
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6.2.2
6.2.3
6.3
Training
Intended Use Requirements
Performance
Functional
Interface
Environmental
Electro-Magnetic Compliance (EMC)
Product/System compatibility
Reliability
Maintainability
Serviceability
Storage and shelf life
Materials
Regulatory requirements
Human factors
Safety
Sterilization
Standards
System and Product Development Requirements
Cost
Technological viability
Manufacturability
Export requirements
Packaging and shipping
Other business considerations
Delivery and installation
Statutory requirements
Contract review results
6.4
Functional Requirements
These specify what the product does, focusing on its operational capabilities and
the processing of inputs and resultant outputs.
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6.4.2
Performance Requirements
These specify how much or how well the product must perform, addressing such issues
as speed, strength, response times, accuracy, limits of operation, etc. This includes a
quantitative characterization of the use environment, including temperature, humidity,
shock, vibrati9on, electromagnetic compatibil9ity, etc. Product reliability and safety
requirements also fit in this category.
6.4.3
Interface Requirements
These specify characteristics of the product, which are critical to compatibility with
external systems. More specifically, these are characteristics mandat4ed by external
systems and outside the control of the developers. One interface to always address is the
user and/or customer interface.
6.4.4
System and Product Development Requirements
These specify goals and requirements of the product development and other
development issues that are not necessarily just a characteristic of the product itself.
Typically, these are a consequence of development, manufacturing, and support of the
product.
6.5
6.6
6.7
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of the review, the EMT approves the MRD if acceptable, marking the end of the research phases
(Concept/Feasibility) and the start of the development program. The MRD is a design history
document maintained in the Design History File.
6.8
6.9
Change Control
As discussed above, reviews, verification, and other development activities often uncover
discrepancies, errors, or new information that requires changes to the design input requirements.
The Product Development Team must carefully manage the change control process to prevent a
change that corrects one problem but creates another. To minimize such an occurrence, the PDT
ensures that all potential changes are communicated to developers who can determine the full
impact of the change. The Product Manager of a specific development program is responsible for
controlling and documenting changes to the design input requirements in the MRD. The EMT
approves all updates and changes to the MRD.
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