This Labeling Procedure complies with ISO 13485:2016, ISO 15223-1:2021, BS ISO 20417:2021, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines requirements for creating, approving, controlling, and applying labels to ensure accuracy, traceability, and regulatory compliance. Digital delivery within 24 business hours.
This procedure outlines controls for label creation, content verification, approval workflows, printing, application, and inspection, including requirements for Instructions for Use (IFU). It defines UDI labeling requirements, storage and control of label masters, prevention of mix‑ups, and documentation of all labeling activities. The procedure also specifies language requirements for labeling and IFUs to ensure regulatory compliance. 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.