This Design Control Transfer & Changes Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines requirements for transferring designs to production and managing post‑design changes in a controlled, documented manner. Ensures regulatory‑compliant product realization. Digital delivery within 24 business hours.
This procedure outlines the processes for design transfer planning, production readiness verification, documentation updates, and controlled implementation of design changes. It includes change evaluation, approval routing, traceability, and communication requirements to ensure consistent product quality. Delivered in editable Word format for easy customization. Consultancy support is available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are available for an additional fee.