Medical Device Post-Market Surveillance Inquiry Form Template

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About this free form template

Medical Device Post-Market Surveillance Made Simple

Post-market surveillance is a critical regulatory requirement for medical device manufacturers, distributors, and healthcare facilities. This Medical Device Post-Market Surveillance Inquiry Form template streamlines the entire reporting process—from initial complaint intake through investigation, corrective action, and regulatory notification.

Whether you're managing a quality assurance program, responding to adverse event reports, or maintaining ISO 13485 compliance, this template captures all essential information in a structured, professional format. The form guides reporters through device identification, event details, patient impact assessment, and complaint severity classification, ensuring you collect complete information for regulatory bodies like the FDA, Health Canada, or EU notified bodies.

Built for Medical Device Compliance Workflows

Paperform's conditional logic adapts the form based on event severity and device risk classification, showing relevant fields for serious adverse events that may require expedited reporting. You can collect supporting documentation like photos, test results, or clinical records directly within the form, and use Papersign to gather authorized signatures on investigation reports or corrective action plans.

Connect your surveillance form to Stepper workflows to automatically route high-priority incidents to quality managers, trigger investigation timelines, update your complaint management system, and generate regulatory reports. Integration with tools like Jira, Monday.com, or quality management software ensures every complaint flows seamlessly into your existing post-market surveillance infrastructure.

Complete Visibility and Audit-Ready Records

With Paperform's SOC 2 Type II compliance and detailed submission tracking, you maintain a complete audit trail for regulatory inspections. Use AI Insights to identify trending issues across device batches, analyze complaint patterns, and generate executive summaries for periodic safety update reports (PSURs) or management reviews.

This template is trusted by medical device manufacturers, contract manufacturers, importers, healthcare facilities, and regulatory consultants who need a professional, secure solution for post-market surveillance that meets global regulatory expectations without requiring custom software development.

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