This Identification and Traceability Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines methods for identifying products, components, and materials throughout all stages of manufacturing. Ensures full traceability from receipt to distribution. Digital delivery within 24 business hours.
This procedure establishes controls for product identification, labeling, lot tracking, and traceability throughout the product lifecycle. It covers material receipt, in‑process identification, device history records, labeling requirements, and traceability documentation. 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.