When Complaint Handling Is Not Enough

Post-Market Safety Governance and the ISO 14971 §10.3 Failures Behind Recurring Field Actions, Warning Letters, and CAPA Recurrence

von Devin Montagne Mack

498 Seiten, Taschenbuch

Kurzbeschreibung des Verlags

When complaint handling is treated as paperwork, the same failures keep coming back.

Recurring field actions. Repeat CAPAs that never quite hold. Warning letters that cite the same gap a competitor was cited for last year. Behind each one is a complaint that was filed and closed instead of evaluated as what it actually is - a post-market safety signal.

When Complaint Handling Is Not Enough makes a single, consequential argument: under ISO 14971:2019, complaint handling is a Section 10.3 production and post-production safety evaluation - a risk-management obligation - not a quality-system filing task. That reframing changes how a complaint moves through your organization, and it is the difference between closing a record and actually controlling a hazard.

This book gives you the discipline to do it. At its core is a causal chain that traces every complaint from device characteristic to hazardous situation to harm, so that reportability decisions, corrective-action urgency, and residual-risk acceptability each rest on evidence rather than instinct. You will learn to separate the question "is this reportable?" from the question "how fast must we act?" - two determinations that are routinely, and dangerously, collapsed into one.

The framework is then applied where it is hardest: across six device classes with distinct failure signatures - endoscopes, catheters, IVD analyzers, combination products, wearable delivery systems, and software as a medical device. Each chapter shows how class-specific complexity defeats a generic complaint process, and how a Section 10.3 architecture holds where that process fails.

It is written for the people who carry post-market risk: regulatory and quality leaders, complaint-handling and post-market surveillance teams, CAPA owners, internal auditors, and the consultants who have to make these systems defensible.

And it is written for this moment. With the FDA Quality Management System Regulation (QMSR) harmonizing 21 CFR Part 820 with ISO 13485 as of February 2, 2026, EU MDR and IVDR raising post-market surveillance and vigilance expectations, intensified scrutiny of human factors and use-related risk, and the transition from MAUDE to the FDA's new adverse-event reporting system, the gap between "complaint handling" and "safety evaluation" is precisely where inspections now land.

Inside you will find fourteen chapters of governance architecture, worked examples grounded in real enforcement patterns, and ready-to-adapt templates - including a hazard-and-harm causal-chain worksheet, corrective-action effectiveness checks, a phase-readiness assessment, a defined-terms glossary, and a consolidated reference set spanning the applicable U.S. regulations, EU regulations, and international standards.

Stop re-closing the same complaints. Build a Section 10.3 governance record that explains itself to an investigator, survives an audit, and breaks the cycle of recurrence.

• ISBN: 9798994787724
• Sprache: Englisch
• Erscheinungsdatum: 02.06.2026
• Größe: 229 x 152 mm
• Verlag: Amazon Digital Services LLC - Kdp