Product Development

Chapter 6

Definitions needed:

Verification: The process of evaluating

compliance to regulations, standards, or
specifications.

Validation: The process of documenting that

a solution or process is correct or suited for
its intended use.

Product Development

A product development process ensures that

the design, development, and transfer of a
new or modified medical device will result in a
product that is safe, effective, and meets user
needs and intended use requirements.

Product
Requirements

The Product
Development
Process, details to
follow

Design/Development
Planning

System
Requirements
Specification

Requirements
Design
Review

Design
Inputs

Design
Outputs

Design
Reviews

Design
Verification

Design
Validation

Design
Transfer

Design
Reviews

Product Requirements Page

1:

User / patient / clinical performance

characteristics
Privacy and security
Safety
Regulatory
Quality
Reliability

Product Requirements Page

2:

Compatibility with accessories / auxiliary

devices or products
Compatibility with the intended
environment
Human factors
Physical characteristics
Sterility
Manufacturability

Product Requirements Page

3:

Serviceability
Labeling, packaging, storage
Requirements for intended markets
(domestic or international).

includes the needs of users & patients &

intended use of the device

Design & Development Plan

Program Goals
Design and Development Elements
Organizational and Key Interfaces
Deliverables and Responsibilities
Design and Development Schedule
Approve Design and Development Plan
Incorporate Updates to Design and
Development Plan

System Requirements
Specification

Functional Requirements
Physical and Performance Requirements
Interface Requirements
System Architecture
Software Requirements (if applicable)
Resolve problems in design reviews
Logs kept in design history file

Design Input
Each product program must establish Design
Inputs to ensure that design requirements
relating to a device are appropriate and
address the intended use of the device,
including the needs of the user and patient.
There should be a mechanism for addressing
incomplete, ambiguous, or conflicting
requirements.

Design Output:
Intermediate

Preliminary design specifications

Models and prototypes
Software source code
Risk analysis results
Traceability documents
Biocompatibility and bioburden test results
Other intermediate design outputs as
appropriate.

Design Output: Final, part

1

Device Specifications
Device Drawings
Component
Assembly
Finished Device

Design Output: Final, part

2

Composition, formulation, component

specifications
Sub-assembly specifications (if
applicable)
Component and material specifications
Product configuration documents
Parts list
Bill of Materials

Design Output: Final, part

3

Software specifications (if applicable)

Software machine code, such as a diskette or
master EPROM.
Production Process Specifications
Critical Production Process Specifications
Equipment Specifications

Design Output: Final, part

4

Production methods and procedures

Test protocols
Work instructions
Production environmental specifications
Quality Assurance Procedures and
Specifications
Acceptance criteria
Purchasing and acceptance requirements
Quality assurance equipment to be used

Design Output: Final, part

5

Production methods and procedures

Test protocols
Work instructions
Production environmental specifications
Quality Assurance Procedures and
Specifications
Acceptance criteria
Purchasing and acceptance requirements
Quality assurance equipment to be used

Design Output: Final, part

6

Packaging and Labeling Specifications

Including Methods and Processes Used
Installation, Maintenance, and Servicing
Procedures and Methods
Installation instructions
Service and maintenance instructions

Formal Design Review

Formal Design Reviews are performed at
major decision points or milestones in the
design process as specified by the Design
and Development Plan. They are intended to
be a systematic assessment of design results
and to provide feedback to designers on
existing or emerging problems. Each Formal
Design Review must ensure that design
outputs meet design inputs & track resolution.

Design Verification

Design Verification Plan (including

requirements & displays & packaging)
Design Verification Test Methods
(integration, functional, accuracy, etc.)
Design Verification Report (summary of
above)

Design Validation

Design Validation Plan (software, external,

process, risk, labeling, packaging,)
Design Validation Test Methods
(simulated use, workload, safety, etc.)
Design Validation Report

Design Transfer
Design Transfer ensures that the device
design is correctly translated into production
specifications and that the finished device is
successfully transferred from design to
production and service. Production
specifications ensure that devices are
repeatedly and reliably produced within
product and process capabilities.