This Design Control Planning & Development Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines the structured approach for planning, controlling, and documenting all design and development activities. Ensures regulatory‑compliant product realization from concept through design outputs. Digital delivery within 24 business hours.
This procedure outlines requirements for design planning, design inputs, design outputs, design reviews, and design documentation. It ensures controlled development activities, proper risk consideration, and traceability throughout the design lifecycle. Delivered in editable Word format for full customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.