Design and Development Planning Form

Project Name: [Device Name]

DHF Number: [ZZZZ]

Design and Development phase: Feasibility, Design, Development, Industrialization, Market Launch, Post-commercialization Select the phase

Scope

This Design & Development (D&D) Planning applies to the design and development activities for [Device Name] under DHF [DHF Number] (including [variants/configurations/accessories/software components, if applicable]) from project initiation through design transfer and design freeze/release, as defined by the project phase gates according to QSP-DES-001 Design Control Procedure. It covers the planning and execution of design controls including: design inputs, design outputs, design reviews, verification, validation, traceability, risk management integration, design changes during development, and transfer readiness.

This plan applies to all internal functions and external parties participating in or influencing design and development activities for this project, as applicable.

Project description

Device description

Replicate the content from the corresponding sections of the User Requirements document in this section (in the initial phase of design and development) or more current documents according to the progress of the design and development (e.g., extracted from the Technical Documentation or the IFU) ensuring consistency and traceability.

Proposed intended use

Replicate the content from the corresponding sections of the User Requirements document in this section (in the initial phase of design and development) or more current documents according to the progress of the design and development (e.g., extracted from the Technical Documentation or the IFU) ensuring consistency and traceability. Note: remove “proposed” when the intended use statement is frozen.

Markets of interest and corresponding regulatory requirements

The following markets of interest are in scope of the design and development of the device with the corresponding regulatory requirements that must be met throughout the project.

Source: User Requirements document

Table 1: Market of interests

Markets of interest	Applicable regulatory requirements
Europe	(EU) 2017/745 as amended

Traceability

Current DHF: ZZZZ-DHF

Current Traceability Matrix: ZZZZ-TM-XXX rev.Y

Resources

Team members

Core Team (CT) members are responsible for the day-to-day execution of the project and are actively involved throughout the design and development phases. Technical Support (TS) members provide subject-matter expertise and are engaged as needed, at the request of the Core Team.

The project requires the competencies listed below to ensure effective execution of the design and development activities and compliance with applicable quality and regulatory requirements. Table 2 identifies the individuals assigned to the Design and Development activities for [Device Name], including their department and/or position and their planned involvement by project phase.

Table 2: Team members

Required competency/role	Department/Position	Involvement by phase
		F	Ds	Dv	I	L
Project Management		CT	CT	CT	CT	CT
PRRC		TS	TS	TS	TS	CT
Specialist in market need Market Needs / Product Management Representative		CT	TS	TS	TS	CT
Design engineer		TS	CT	CT	CT	CT
Software engineer / software architect		TS	TS	TS	TS	TS
Cybersecurity expert		TS	TS	TS	TS	TS
Software validation		TS	TS	TS	TS	TS
Industrialization / Manufacturing Engineer		TS	TS	TS	TS	TS
Regulatory specialist under MDR		CT	CT	CT	CT	CT
Medical expert for management of clinical data		TS	TS	TS	TS	TS
Validation expert		TS	TS	TS	TS	TS
Quality Engineer (industrialization)		TS	TS	TS	CT	CT
Quality management system specialist		TS	CT	CT	CT	CT

Phases: F: feasibility / Ds: Design / Dv: Development / I: Industrialization / L: Market Launch

Team member: CT: Core Team member / TS: Technical Support member / “blank”: no involvement in the phase.

In addition, to the individuals within [Company Name], external resources will be required during the design and development of [Device Name].

Table 3: External human resources

Required competency/role	Service provider / subcontractor	Name	Involvement by phase
			F	Ds	Dv	I	L
Include the role/competency required	Include the name of the company selected	Include the name of individual selected/point of contact	Yes	Yes	Yes	Yes	Yes

Records for suitability of required human resources, are maintained as part of the related [Company Name] quality management system (QMS) processes (i.e,, Human resources or Supplier management).

Responsibilities and Authorities

Core-team authorities and responsibilities are defined in Table 4 for the design and development project of [Device Name]. For each core-team member, the individual name, scope of responsibility (see Table 2 and Table 3), decision-making authority and review and approval responsibilities are identified.

Assigned authorities ensure that decisions are made within each functional area during design and development activities. When an issue cannot be resolved at project level, when timelines or resources are impacted, or when significant quality, regulatory, technical, or project risks are identified, the matter shall be escalated to the direct manager and/or the next level of management, as applicable.

Approval responsibilities are defined to identify the functions acting as reviewer and/or approver for relevant deliverables during the design and development process. In the absence of the designated core-team member, the review and/or approval responsibility may be delegated to the direct manager and/or the next level of management, as applicable.

Table 4: Core-team authorities and responsibilities

Department / Position	Name	Authority	Approval responsibility
Consider the departments positions of core team members described in Table 2 and Table 3.	Indicate the Name of the employee	Direct Manager: XXXX indicate the direct manager in case of issue (for escalation) Responsible for: XXXX indicate the Technical Support’s employee under the responsibility of this core-team member	Reviewer for XXX indicate the approval role (e.g., reviewer for regulatory affairs) Approver for XXX indicate the approval role (e.g., approver for TD documents)

In the event of a specific issue involving several functions, or in case of a general disagreement affecting the design and development activities, which cannot be resolved by the core team, the matter shall be escalated to the relevant direct managers and/or the next level of management, as applicable. A dedicated meeting may be organized to review the issue, align the involved functions, and support decision-making. The decision, including any resulting actions and responsibilities, shall be documented in the minutes of the meeting to ensure appropriate continuation of the design and development process.

Other Resource needed

The Core Team shall identify and secure the resources required to execute the design and development activities for [Device Name]. Resources include, as applicable, infrastructure, equipment, software tools, test methods, external services (e.g., laboratories), and any specialized facilities required for design, prototyping, verification, validation, and design transfer.

Note: The adequacy and availability of resources is approved at project initiation and reviewed at each phase gate (or when significant changes occur).

Where required, the following must be considered (non-comprehensive list):

• Measurement and test equipment used to generate verification/validation evidence.
• Computer software in quality-related processes (e.g., requirements management, traceability, electronic signatures, test management, QMS repositories)
• Specialized infrastructure and work environment needs (e.g., clean areas, ESD protection, controlled environmental conditions)
• Externally provided services (e.g., test laboratories)

Note: the suitability of the resources will be monitored, verified and/or validated as necessary to confirm they can be suitably used throughout the design and development of [Device Name]. Those activities are embedded in the D&D planning.

Records for suitability of required resources, associated qualification/validation/calibration (as applicable), and approvals are maintained as part of the related [Company Name] quality management system (QMS) processes (e.g., Supplier management, Calibration).

The following table summarizes the resources required for the project.

Table 5: External resources

Resource category	Resource / description	Related activity	Owner	Need by (phase/date)	Status	Planned control
Infrastructure, Equipment, software, test method, manufacturing resources, documentation system, etc.	Describe the needed resource (e.g., new caliper, clean room, packaging equipment, testing software)	Indicate the intended use (e.g., protyping, equipment of control; verification test, etc.)	Department or individual	Feasibility, Design, Development, Industrialization, Market Launch, Post-commercialization	To be acquired; Available but not operational; Operational	Indicate the plan / or the records when available

Schedule

The schedule for the design and development project of [Device Name] is summarized in Table 6. Risk management activities are planned throughout the project, from feasibility to market launch, starting with the planning of the risk management strategy and continuing through risk analysis, risk evaluation, risk control, and determination of the overall benefit-risk profile, as documented in the risk management file.

Verification activities are planned during Phase 3 – Development and/or Phase 4 – Industrialization, as applicable, using respectively prototypes or devices representative of the final product design. Validation activities are planned during Phase 4 – Industrialization on finished devices, initial production units, or equivalent devices, as justified and documented. The project is considered finalized once the Device Master Record (DMR) has been established, approved, and signed, and once design transfer has been completed to confirm that the device can be consistently manufactured at the intended production level.

A detailed living operational schedule covering project activities, responsibilities, and target dates is maintained under a XXXX Excel Spreadsheet / Gantt Chart and is reviewed and approved before each design review (see Appendix I – Operational design and development planning)

Table 6: Design and development schedule

Overall project schedule		Comments
Project start date	[XX-Month-YYYY]	Justify any gaps as compared to the previous plan
Design transfer	[XX-Month-YYYY]	Justify any gaps as compared to the previous plan
Project timeline and milestones		Comments
Project kick-off	Project start date
Phase 1 – Feasibility	Design review planned on [XX-Month-YYYY]	Justify any gaps as compared to the previous plan
Phase 2 – Design	Design review planned on [XX-Month-YYYY]	Justify any gaps as compared to the previous plan
Phase 3 – Development	Design review planned on [XX-Month-YYYY]	Justify any gaps as compared to the previous plan
Phase 4 – Industrialization	Design review planned on [XX-Month-YYYY]	Justify any gaps as compared to the previous plan
Phase 5 – Market launch	Design transfer

Approval

Revision	Date	Change History

Approval
Name
Position
Date
Signature

Appendix I – Operational design and development planning