Product Realisation Planning Template - ISO 13485

Ensure a structured, compliant, and efficient approach to medical device product realisation with our ISO 13485:2016 Clause 7.0 Product Realisation Planning Procedure Template. Proper product realisation planning is essential for ensuring that medical devices are designed, manufactured, and delivered in accordance with regulatory requirements, quality objectives, and customer needs. This structured procedure template provides a step-by-step framework for planning product realisation, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Product Realisation Planning Procedure – Covers key ISO 13485:2016 Clause 7.0 requirements.

✔ Product Development & Manufacturing Planning – Establish a structured workflow for design, production, and validation.

✔ Quality & Regulatory Compliance Integration – Ensure that each stage aligns with ISO 13485 and industry regulations.

✔ Resource & Risk Management Approach – Define required personnel, materials, and risk mitigation strategies.

✔ Monitoring & Measurement Controls – Implement procedures for tracking performance and ensuring compliance.

✔ Customer & Supplier Requirements Consideration – Align with customer expectations and supplier capabilities.

✔ Audit-Ready Documentation & Traceability – Maintain structured records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for different medical device classifications and business needs.

This ready-to-use product realisation planning procedure template is ideal for quality managers, production teams, and regulatory professionals, ensuring a structured, compliant, and efficient product lifecycle.

Download the ISO 13485:2016 Product Realisation Planning Procedure Template today and enhance your quality management system!