A Brief Guide To Design Development Plan

REGULATORY ROUNDUP
Martin King
A Brief Guide to
Design Development Plan
© 2024 Martin King any logos are copyright © of the organisation m.king@bluewin.ch
Learning Goals
What is a Design Development Plan.
Design Development Plan as a Regulatory

Requirement.
How the Design Development Plan

typically integrates into the “Product
Realisation” Process.
The Input sources of a Design

Development Plan.
Design Development Plan: Language,

Format, Content, Form and Structure.
The role of the Design Development Plan

across the Entire Product Lifecycle.
medtech leading voice

Project Plan Differences
The Design Development Plan ensures
compliance with design controls, while
the Project Plan ensures successful project
execution.
Properties Design Development Plan Project Plan
Guides the design and Manages the overall project,
Purpose development process for a including timelines, resources, and
specific medical device. milestones.
Focused on design activities,
including requirements, Encompasses the entire project,
Scope
specifications, and from initiation to completion.
verification/validation.
Aligns with FDA 21 CFR Part Not specifically tied to regulatory
Regulatory
820 and ISO 13485 design standards but ensures project
Compliance
control requirements. success.
Includes design inputs, outputs, Addresses project goals, tasks,

Content risk management, verification, schedules, budget, team roles,
validation, and change control. and communication.
Primarily for the development

Relevant to project managers,
Audience team, quality assurance, and
stakeholders, and team members.
regulatory personnel.
Varies based on project duration
Typically spans the entire
Timeline and phases (initiation, planning,
product development lifecycle.
execution, closure).
Iterative and evolves as the May be revised periodically based

Updates
design progresses. on project milestones or changes.
Linked to risk management, Influences resource allocation,

Dependencies design reviews, and validation task sequencing, and project
activities. milestones.
Regulations
Design Control Guidance (fda.gov)
FDA 21CFR820.30
− Design Development Planning 21 CFR 820.30(b)

− (b) Each manufacturer shall establish and maintain
plans that describe or reference the design and
development activities and define responsibility for
implementation.
− The plans shall identify and describe the interfaces
with different groups or activities that provide, or
result in, input to the design and development
process.
− The plans shall be reviewed, updated, and approved
as design and development evolves.
“activities that provide, or

result in, input to the
design and development
process” are before the
design & development!

Standards
ISO 13845:2016
7.3.2 Design and development planning
The organization shall plan and control the design and
development of product. As appropriate, design and
development planning documents shall be maintained
and updated as the design and development progresses.
During design and development planning, the organization
shall document:
− the design and development stages;
− the review(s) needed at each design and
development stage;
− the verification, validation, and design transfer
activities that are appropriate at each design and
development stage;
− the responsibilities and authorities for design and
development;
− the methods to ensure traceability of design and
development outputs to design and development
inputs;
− the resources needed, including necessary
competence of personnel.

EU Regulations
EU MDR 2017/745 EU IVDR 2017/746
Article 10
General obligations of manufacturers
The quality management system shall address at least

the following aspects:
(g) product realisation, including planning,
design, development, production and service
provision;

Regulatory Necessity
Properties Description
The Design Development Plan shows conformity
Regulatory Compliance with regulatory standards for medical device
combination products.
The Design Development Plan navigates
interactions, interfaces, and responsibilities,
Risk Mitigation
outlining a methodical risk assessment to assure
patient safety.
The Design Development Plan provides
Transparent
oversight of device development, identifying
Responsibility
accountability and aiding regulatory oversight.
The Design Development Plan ensures product
Quality Assurance safety and effectiveness through implementing
quality measures.
The Design Development Plan establishes a
Consistency framework for consistent and dependable
development processes.
Documentation of Design The Design Development Plan provides
Controls / Product documented evidence required for regulatory
Realisation submissions and audits.
The Design Development Plan can assist in
Streamlining Regulatory
expedited regulatory assessments by providing
Assessments
oversight of the development approach.
The Design Development Plan aids in the
Risk Mitigation for
proactive identification and management of
Post-Market Surveillance
potential risks for post-market surveillance.

Definition
− A Design Development Plan is a regulatory
requirement mandated by many regulatory
bodies, integral to the quality management
system.
Key contents are; design and development
stages, mandated reviews, verification and
validation activities, responsibilities and
authorities, methods for traceability, and
resource requirements throughout the
product realization process, from initial
planning to production and service
provision, addressing regulatory obligations
and industry standards.
A Design
Development Plan
is a Regulatory
Requirement

A Living Document
The design development plan

is reviewed, updated, and
approved at each design Stage
(stage gate review) to adapt to
evolving design and development
dynamics.

Inputs
By taking into account these inputs, can help create
an effective and compliant Design Development
Plan.
Project Requirements: Thorough specifications
outlining the project requirements, covering the
intended use of the product, target applications,
intended indications for use, and any distinct
constraints or limitations.
Project
Requirements
Design
Development
Plan

Inputs
Regulatory & Standards: Regulations,
guidance, and standards that are obligatory to
apply during the development process of a
particular product type. These requirements help
ensure conformity with legal and industry
standards.
Project
Requirements
Regulations
Standards
Design
Development
Plan

Inputs
Risk Management: Information can include
data derived from evaluations and assessments
and analyses aimed at identifying potential
hazards, risks, and strategies for mitigation.
This data serves to guide the planning phase and
provide input to the development team for
addressing safety by design.
Project
Requirements
Regulations
Standards
Risk
Management
Design
Development
Plan

Inputs
Identifying user needs and expectations is
essential for realising a product that aligns with
customer demands and ensures a safe and
effective user experience.
Project
Requirements
Regulations
Standards
Risk
Management
Design
User Needs
Development
Plan

Inputs
Market research: gathers key information from
various sources such as competitive analysis,
customer feedback, and market trends. This
data is utilized to make informed design
decisions and validate the product's market
potential.
Project
Requirements
Regulations
Standards
Risk
Management
Design
User Needs
Development
Market Research Plan
Inputs
Past Experiences: Insights and lessons from
prior design and development projects hold
significant value, aiding in the avoidance of past
errors and enhancing efficiency.
Project
Requirements
Regulations
Standards
Risk
Management
Design
User Needs
Development
Past Experiences

Inputs
Technical Expertise: State-Of-The-Art SOTA

Technical and Scientific Understanding pertinent
to the product's domain helps to ensure the
design integrates state-of-the-art solutions.
Project
Requirements
Regulations
Standards
Risk
Management
Design
User Needs
Development
Past Experiences
Technical
Expertise

Inputs
Cross-Functional Input: Incorporating
perspectives from different departments and
stakeholders across the organization, including
engineering, quality assurance, regulatory affairs,
marketing, and manufacturing, to foster a
thorough and cooperative strategy.
Project
Requirements
Regulations
Standards
Risk
Management
Design
User Needs
Development
Past Experiences
Technical
Expertise
Cross-Functional
Inputs

Inputs
Resource Management: When drafting a
Design Development Plan, it’s important to
prioritize the allocated resources, such as
budget, time, subject matter expertise and
personnel. This ensures that the plan remains
feasible and can be successfully executed
within the available means.
Project
Requirements
Regulations
Standards
Risk
Management
Design
User Needs
Development
Past Experiences
Technical
Expertise
Cross-Functional
Inputs
Resource
Management

Language, Format, Structure
While a template may help provides the form
and structure for the Design Development
Plan (DDP), the content and use of language is
key for accurately communicating what is
required.
Structure each part of

the Design
Development Plan, to
assure that the purpose,
objectives, and
methodologies are
clear and unambiguous
to the readers.

Language, Format, Structure
The audience is typically diverse that will review
the Design Development Plan including but not
limited to: Management, Project Team, Auditors,
Conformity Assessment Bodies etc. Apply
language that is easily understood by technical
experts and non-experts, regulatory
authorities and stakeholders. Take care to
utilize the standard terminology prescribed by
the regulatory authorities.

Contextual Detail
Provide sufficient detail to assure
understanding. There may be a need to provide
the rationale supporting approaches,
methodologies, or design decisions.
Apply a progressive detailing approach

breaking down high-level concepts into
specific details. This will help the audience to
understand the overall strategy and finer
points.

Compliance
Use terms and language that aligns with

regulatory compliance. Clearly identify how
and where the design and development
processes comply with applicable regulations
and standards

Risk Management
Use terms and language that aligns with
regulatory compliance. Clearly identify how
and where the design and development
processes comply with applicable regulations
and standards
Communicate identified risks and the risk-
mitigation-strategies in place to address
them. Use appropriate language that conveys
the control, severity, and probability of risks.

Evidence based Claims
Where applicable: support any claims with
evidence and data. This will help add credibility
to the plan and demonstrates a thorough
approach to design and development.

Feasibility and Constraints
Set realistic expectations by clearly identifying
and addressing feasibility considerations or
constraints that may impact the design and
development, express them clearly. This helps
set realistic expectations.

Cross Referencing
Apply cross-referencing within the Design
Development Plan to ensure consistency and
traceability. Use terms, abbreviations, or
concepts consistently throughout the plan to
assure a cohesive narrative and easier to
maintain documentation.

Planning Iterations
First-Time-Right should always be the standard
goal when approaching medical device
development. BUT still plan iterations of the
design and development with clear and
succinct rationale. Define how feedback,
testing, ongoing evaluation and assessments
contribute to timely completion of a Safe and
Effective product.

Communication
Balance communication without avoiding
critical information, the clear goal of ensuring
that all actors are kept at the same level of
understanding throughout the design and
development process.

The Future
Outline what the future holds, consider future
developments and improvements. This
demonstrates foresight and motivation for
continuous product improvement.

Consistency
Maintain consistency not just in terminology
but also in the tone and style of language
employed across the Design Development Plan.

Review and Approval
Clearly outline the procedures for reviewing
and approving documents. Clarify how
feedback is integrated and how final
authorization is obtained.

Across the Whole Life Cycle
The Design Development Plan serves as a
dynamic record throughout the entire product
lifecycle.
Beginning with the initial conceptualization and
continuing through feasibility studies,
manufacturing, post-market surveillance, and
ultimately product discontinuation, it
guarantees that design and development
processes are meticulously organized, adhere
to regulatory standards, and promote continual
enhancement and flexibility in response to the
changing demands of the product and its users.

Across the Whole Life Cycle
The Design Development Plan is established at
the very beginning before the product
It outlines the project scope, objectives, and
the overall approach to design and
development.

Risk Management
The Design Development Plan highlights
potential hazards linked to the design and
development process, laying the groundwork for
strategies to mitigate risks during Development
and Design Verification.

Navigation
The Design Development Plan functions as a
map for the development team, offering a
systematic strategy for carrying out the design
procedure.

Navigation
The Design Development Plan delineates the
steps for design verification and validation,
guaranteeing adherence to predetermined
requirements and specifications to ensure the
product's compliance.

Design Transfer
The Design Development Plan incorporates
protocols for transitioning the design into the
manufacturing stage. This guarantees that the
design intent is faithfully conveyed across to the
production process.

Quality Assurance
The Design Development Plan aids in
implementing quality assurance protocols
throughout the manufacturing process, ensuring
compliance with regulatory guidelines.

Adaptation to Feedback
The Design Development Plan should point to
measures for post-market surveillance,
directing the observation of the product's
performance in real-world conditions.

Post Market Surveillance
The Design Development Plan addresses the
approaches for handling feedback, complaints,
and adverse events, facilitating continuous
improvement to the product.

Regulatory Compliance
The Design Development Plan functions as an
important document for regulatory
submissions, showcasing compliance with
design and development criteria.

Audit Readiness
The Design Development Plan assists in
readiness for regulatory & QMS audits by
providing a thorough record of the design and

Change Management
The Design Development Plan addresses the
approach for handling design changes,
guaranteeing that changes are adequately
documented, validated, and communicated
across the product lifecycle.

Discontinuation Management
When a product nears the conclusion of its
lifecycle, the Design Development Plan may
steer the strategy for retirement or
discontinuation, tackling concerns like product
recalls or transitioning to new technologies.

Continuous Improvement
The Design Development Plan provides a
continuous improvement loop by integrating
feedback gathered throughout different phases of
the product lifecycle. This contributes to the
refinement of subsequent designs and
procedures.

Continuous Learning
Through Design and Development
governance, the Design Development Plan
provides a platform for continuous learning and
improvement.

Thank you
I trust you’ve found this information useful.
• Giving proper consideration and focus on a precise,
thorough, and well-managed Design Development
Plan is important for the effective development,
manufacturing, marketing, and post-market
surveillance of any device.
• The Design Development Plan acts as a foundational
roadmap for product development and
manufacturing.
• After market launch, it transforms into a key document
for supporting the product across its market lifetime.

REGULATORY ROUNDUP
Martin King
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REGULATORY ROUNDUP

Design Development Plan as a Regulatory

How the Design Development Plan

The Input sources of a Design

Design Development Plan: Language,

The role of the Design Development Plan

medtech leading voice

Includes design inputs, outputs, Addresses project goals, tasks,

Primarily for the development

Iterative and evolves as the May be revised periodically based

Linked to risk management, Influences resource allocation,

− Design Development Planning 21 CFR 820.30(b)

“activities that provide, or

medtech leading voice

medtech leading voice

The quality management system shall address at least

medtech leading voice

medtech leading voice

medtech leading voice

The design development plan

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

Technical Expertise: State-Of-The-Art SOTA

medtech leading voice

medtech leading voice

medtech leading voice

Structure each part of

medtech leading voice

medtech leading voice

Apply a progressive detailing approach

medtech leading voice

Use terms and language that aligns with

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

medtech leading voice

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