This Medical Device Reporting Procedure complies with ISO 13485:2016, EU MDR 2017/745, and FDA QMSR 21 CFR 820. Delivered in editable Word format, it defines processes for reporting adverse events, incidents, and device malfunctions to regulatory authorities. Digital delivery within 24 business hours.
This procedure ensures timely and accurate reporting of medical device incidents to regulatory bodies, protecting patient safety and maintaining compliance. It covers adverse event identification, documentation, reporting timelines, and communication with authorities. Delivered in editable Word format for customization. Consultancy services are available via email, Zoom, or on‑site visits. Full implementation or signed, approved procedures are offered at an extra fee.