This Medical Device / Technical File Procedure complies with ISO 13485:2016 and EU MDR 2017/745. Delivered in editable Word format, it defines requirements for creating, maintaining, and updating the Technical File to demonstrate conformity of medical devices throughout their lifecycle. Digital delivery within 24 business hours.
This procedure outlines the structure, content, and maintenance requirements for the Medical Device / Technical File, including design documentation, risk management, labeling, clinical evaluation, post‑market surveillance, and manufacturing information. It ensures regulatory‑compliant documentation for audits and notified body assessments. 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.