Product Development Chapter 6. Definitions needed: Verification: The process of evaluating compliance to regulations, standards, or specifications.

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.

ProductRequirements

Design/DevelopmentPlanning

System RequirementsSpecification

RequirementsDesignReview

DesignInputs

DesignOutputs

DesignReviews

DesignVerification

DesignValidation

Design Reviews

DesignTransfer

The Product Development Process, details to follow…

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.