This Quality Records Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Provided in editable Word format, it ensures proper identification, storage, protection, retrieval, and retention of quality records. Delivered digitally via email within 24 business hours (excluding weekends and holidays).
This Quality Records Procedure helps medical device manufacturers maintain accurate and traceable records essential for regulatory compliance. Delivered in editable Word format, it can be tailored to organizational requirements. 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.