Description:

This document sets the planning baseline for controlled medical device design and development across defined phase gates.
• Define Scope from initiation to design transfer and design freeze/release, aligned to Design Control Procedure.
• Maintain project traceability via DHF Number and the current Traceability Matrix reference.
• Confirm target markets and applicable requirements, including (EU) 2017/745 for Europe.
• Assign competencies (e.g., PRRC, cybersecurity, industrialization) and define involvement by phase.
• Set Responsibilities and Authorities, including escalation routes and approval responsibilities.
• Plan resource adequacy, including qualification/validation/calibration controls for tools and services.
• Define schedule milestones and embed risk management, verification, and validation timing across phases.

Your needs:

• design and development planning aligned with ISO 13485 requirements
• design and development planning for MDR decision-making
• Reduce late-stage rework by aligning resources, roles, and evidence early.

Use this plan at project initiation and update it at phase gates to keep design controls, risk management, and transfer readiness coordinated under the DHF and traceability system.

Key requirements are summarized below. Phase gates are documented decision points to proceed (or stop) based on readiness, and the Traceability Matrix links requirements to evidence across the lifecycle.
• Define markets and regulatory constraints (including (EU) 2017/745).
• Maintain DHF and traceability references throughout development.
• Assign competent roles and document involvement by phase.
• Control resources (including qualification/validation/calibration where needed).
• Plan verification and validation in the appropriate phases with justified representativeness.
• Integrate risk management activities end-to-end.

Within Lexqara, we support regulatory strategy, QMS implementation, design support, audit readiness, and training to keep your planning defensible and execution efficient. See our Resource Center and Design Control Support for Start-up Companies, and consult EU MDR (Regulation (EU) 2017/745). Request a short planning gap assessment.

A robust D&D plan clarifies ownership, prevents scope drift, and strengthens design transfer outcomes by keeping decisions traceable and evidence-driven.