ISO 13485 (Clause 8.2) - USA Medical Device Vigilance and Reporting for Manufacturers

Maintain compliance with USA medical device regulations through our ISO 13485:2016 Clause 8.2 USA Vigilance and Reporting to the Regulatory Authorities Procedure Template. Vigilance and adverse event reporting are essential for ensuring the safety and performance of your medical devices in the U.S. market. This ready-to-use template provides a structured, comprehensive approach for managing post-market surveillance, adverse events, and reporting requirements to the FDA in compliance with FDA 21 CFR Part 803.

✔ Pre-Formatted Vigilance & Reporting Procedure – Fully aligned with ISO 13485:2016 Clause 8.2 and FDA regulations.
✔ Incident Reporting Framework – Establish clear procedures for identifying, evaluating, and reporting adverse events to the FDA.
✔ FDA Reporting Requirements – Ensure compliance with FDA guidelines for timely, accurate reporting of serious incidents, device defects, and recalls.
✔ Corrective & Preventive Actions (CAPA) – Document CAPA procedures for addressing identified risks and preventing future issues.
✔ Audit-Ready Documentation – Maintain detailed records for FDA inspections, internal audits, and regulatory reviews.
✔ Editable Digital Format – Customizable for various device types and U.S. reporting protocols.

This USA vigilance and reporting procedure template is ideal for regulatory affairs teams, quality managers, and compliance officers, ensuring a compliant, efficient reporting process for the U.S. market.

Download the ISO 13485:2016 USA Vigilance and Reporting Procedure Template today to enhance your post-market surveillance and FDA compliance!