This Management Responsibility Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines top management’s accountability for establishing, maintaining, and reviewing the quality management system. Digital delivery within 24 business hours.
This procedure ensures that executive leadership fulfills its obligations in maintaining an effective quality management system. It covers management reviews, resource allocation, and communication of regulatory requirements. Delivered in editable Word format for easy customization. Consultancy services are available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are offered at an extra fee.