ISO 13485 (Clause 7.3) - Design and Development Plan Template
ISO 13485 (Clause 7.3) - Design and Development Plan Template
Template Overview
Template Overview
Ensure a systematic and regulatory-compliant approach to medical device design and development with our ISO 13485:2016 Clause 7.3 Design & Development Plan Template. Design planning is a critical requirement to ensure that medical devices are developed in accordance with regulatory, safety, and performance requirements, following a structured process that meets ISO 13485:2016, FDA 21 CFR Part 820.30, MDR, and IVDR.
Key Features
Key Features
✔ Pre-Formatted Design & Development Plan – Covers key ISO 13485:2016 Clause 7.3 requirements.
✔ Project Scope & Objectives – Define the purpose, intended use, and development goals.
✔ Design Inputs & Outputs Management – Ensure clear documentation and traceability.
✔ Development Phases & Milestones – Structure project timelines and deliverables.
✔ Risk Management & Compliance Integration – Align with ISO 14971 risk management.
✔ Verification & Validation (V&V) Planning – Establish testing strategies and acceptance criteria.
✔ Roles & Responsibilities Assignment – Define project team responsibilities and approval processes.
✔ Editable Digital Format – Fully customizable for different medical device classifications and development models.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for R&D teams, project managers, and regulatory professionals, ensuring a structured, compliant, and audit-ready design and development process.
Download the ISO 13485:2016 Design & Development Plan Template today and streamline your product development process!
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QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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