Making Agile Native to Design Control

The Regulated Sprint Framework for FDA and EU MDR Compliance

von Devin Mack

404 Seiten, Taschenbuch

Kurzbeschreibung des Verlags

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 themWhether 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.

• ISBN: 9798994787700
• Sprache: Englisch
• Erscheinungsdatum: 01.03.2026
• Größe: 229 x 152 mm
• Verlag: Amazon Digital Services LLC - Kdp