Overview

Medical device and SaMD teams face a persistent conflict: Agile moves fast, but FDA design controls and EU MDR requirements demand documented, traceable, audit-ready evidence at every step. Most organizations resolve this tension by retrofitting compliance after each sprint - creating a hidden tax of rework, audit scrambles, and release delays that adds 20-40% to total development effort. Making Agile Native to Design Control eliminates the retrofit entirely. Drawing on 25+ years of design quality engineering experience across FDA inspections, EU MDR submissions, and SaMD development programs, author Devin Mack presents the Regulated Sprint Framework - a proven methodology that embeds ISO 14971 risk management, IEC 62304 software lifecycle requirements, and FDA 21 CFR 820/QMSR design controls directly into sprint ceremonies, Definition of Done criteria, and team workflows. This is a working reference for quality engineers, regulatory affairs professionals, software teams building SaMD, and consultants who need compliance to be a natural output of development - not a last-minute deliverable. Inside you'll find: The Regulated Sprint Framework mapped to FDA QMSR, EU MDR, and ISO 13485 Sprint-level integration of ISO 14971 risk files, SOUP management, and design traceability PCCP (Predetermined Change Control Plan) planning for AI/ML SaMD Practical RACI matrices, SOPs, and design control templates ready for inspection EU MDR GSPR compliance crosswalks and PRRC accountability structures Real-world 483 patterns and how sprint-native design control prevents them Whether you are preparing for an FDA inspection, navigating EU MDR technical documentation, or building a quality management system that actually scales with Agile velocity, this book gives you the framework, the tools, and the regulatory rationale to make it work.

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