1.
Introduction
This Design and Development Plan (DDP) outlines the activities,
responsibilities, and resources required for the design and development of
XYZ Brand bone plates. This plan adheres to the requirements of ISO
13485:2016 and ensures a systematic and controlled approach to the design
and development process. [Optional: Add a brief statement about leveraging
legacy device data where applicable, e.g., "This plan incorporates a
retrospective approach for [Specific Bone Plate Models] by leveraging
existing data and experience from previous XYZ Brand bone plate designs."]
2. Scope
This DDP covers the design and development of [List specific bone plate
models covered by this plan, e.g., XYZ Brand Locking Plate System, XYZ
Brand Low Profile Plate System, etc.]. It includes all design and development
stages from initial concept to design transfer.
3. Design and Development Stages
Stage Description Deliverables
User Needs Gather and analyze user needs User Needs Report (XYZ-
Assessment and clinical requirements. UNR-[Product Code]-01)
Design Define and document design Design Input Document
Input inputs based on user needs, (XYZ-DI-[Product Code]-
regulatory requirements, and 01)
risk assessment.
Design Develop and document design Design Output
Output outputs, including Specifications (XYZ-DO-
specifications, drawings, and [Product Code]-01)
prototypes.
Design Conduct design reviews at key Design Review Records
Review milestones to assess design (XYZ-DR-[Product Code]-
progress and identify issues. 01)
Design Verify that design outputs meet Design Verification
Verification design inputs. Report (XYZ-DV-[Product
Code]-01)
Design Validate that the design meets Design Validation Report
Validation user needs and intended uses. (XYZ-DVa-[Product
Code]-01)
Design Transfer the design to Design Transfer Plan and
Transfer manufacturing, ensuring Report (XYZ-DT-[Product
production capability and Code]-01)
process validation.
Post-Market Monitor device performance and Post-Market Surveillance
Surveillance safety after market release. Plan and Reports (XYZ-
PMS-[Product Code]-01)
4. Responsibilities
Role/Team Responsibilities
Design Team Lead the design and development activities, develop
design outputs, conduct verification, and support
validation and transfer.
Quality Team Ensure compliance with quality management system
requirements, review design documentation, and
approve design outputs.
Regulatory Affairs Ensure compliance with applicable regulations and
standards.
Manufacturing Develop and validate the manufacturing process,
ensure production capability, and participate in
design transfer.
Clinical Affairs Conduct or oversee clinical evaluations (as needed)
and contribute to design validation.
[Add other
roles/teams as
needed]
5. Resources
Personnel: [List key personnel and their expertise, e.g., Mechanical
Engineers, Bioengineers, Quality Engineers, Regulatory Specialists,
Manufacturing Engineers, Clinical Specialists, etc.]
Equipment: [List equipment required for design and development,
e.g., CAD software, prototyping equipment, test equipment, etc.]
Software: [List software required for design and development, and
confirm its validation status, e.g., "SolidWorks (validated)," "ANSYS
(validated)," etc.]
Facilities: [Specify facilities required, e.g., design lab, prototyping
workshop, cleanroom (if necessary), etc.]
Budget: [Estimate the budget allocated for design and development
activities.]
6. Traceability
Traceability between design inputs, design outputs, verification activities,
and validation activities will be maintained using [Describe the traceability
method, e.g., a traceability matrix, requirement management software, etc.].
7. Verification, Validation, and Design Transfer Activities
Activity Description Methods Acceptance Criteria
Design Verify that [List specific test [Specify acceptance
Verificati design outputs methods and criteria, e.g.,
on meet design standards, e.g., Mechanical strength ≥
inputs. ASTM F382, ISO [Value],
10993] Biocompatibility test
results within
acceptable limits]
Design Validate that the [Describe [Specify acceptance
Validatio device meets validation criteria, e.g., Clinical
n user needs and methods, e.g., data demonstrates
intended uses. Clinical safety and
Evaluation, effectiveness, Device
Simulated Use performs as intended
Testing, in simulated use
Substantial testing]
Equivalence]
Design Ensure the [Describe transfer [Specify acceptance
Transfer design can be activities, e.g., criteria, e.g., All pilot
reliably Process production units meet
manufactured Validation, Pilot specifications, Process
according to Production Run] capability
specifications. demonstrated]
8. Control of Design and Development Changes
All design changes will be documented in a Design Change Log (XYZ-DCL-
[Product Code]-01). Changes will be reviewed, verified, and validated (as
applicable) according to the procedures defined in [XYZ Company Design
Control Procedure - document number].
9. Communication
Regular communication among the design team, quality team, regulatory
affairs, manufacturing, and clinical affairs will be maintained through
[Describe communication methods, e.g., regular meetings, email updates,
design review meetings, etc.].
10. Approvals
Name Title/Role Signatu Dat
re e
[Approver 1] [Title/Role, e.g., Design
Lead]
[Approver 2] [Title/Role, e.g., QA
Manager]
[Add other approvers as
needed]
