This Document Control Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Provided in editable Word format, it ensures proper creation, approval, distribution, and revision of controlled documents. Delivered digitally via email within 24 business hours (excluding Sundays, Saturdays, and holidays).
This Document Control Procedure supports medical device manufacturers in maintaining accurate, approved, and traceable documentation across their quality management system. Delivered in editable Word format, it can be customized to fit organizational needs. Additional support is available for upgrading or adjusting procedures, and consultancy services can be arranged flexibly on an hourly fee basis. For clients requiring full implementation or signed, approved procedures, these services are offered at an extra fee. Our team is available by email, Zoom, or on‑site visits to provide guidance and ensure smooth compliance.