Medical Device Complaint Escalation Form

Medical Device Complaint Escalation Form

Managing medical device complaints requires a structured, compliant approach—especially when adverse events escalate to potential FDA Medical Device Reporting (MDR) requirements or product recall assessments. This Medical Device Complaint Escalation Form gives medical device manufacturers, quality assurance teams, and regulatory affairs professionals a comprehensive tool to capture critical incident details, evaluate severity, and trigger the right next steps.

Why medical device manufacturers trust Paperform

Medical device complaints demand immediate attention, thorough documentation, and seamless handoffs between quality, regulatory, and operations teams. Paperform's conditional logic guides users through the right questions based on severity level, device type, and event circumstances—ensuring you collect everything FDA requires without overwhelming staff with irrelevant fields.

Use Stepper (stepper.io) to automate what happens after submission: route high-severity reports to regulatory affairs, notify quality management systems, create CAPA tickets, and sync data to your compliance platform—all without custom development. When investigations require sign-off or corrective action agreements, Papersign (papersign.com) turns your findings into trackable, auditable eSignature documents that close the loop on every escalation.

Built for regulatory compliance and rapid response

This template is designed for quality engineers, regulatory affairs specialists, and complaint handling teams in medical device manufacturing, covering FDA-regulated Class I, II, and III devices. Whether you're managing a single facility or a global operation, Paperform's SOC 2 Type II compliance, data residency controls, and role-based permissions give you the security and traceability regulators expect.

Ready to streamline your complaint escalation process? Start with Paperform's medical device complaint escalation template and turn every report into a compliant, coordinated response.