{"product_id":"making-agile-native-to-design-devin-mack-9798994787700","title":"Making Agile Native to Design Control: The Regulated Sprint Framework for FDA and EU MDR Compliance","description":"\u003cp\u003eMedical 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.\u003c\/p\u003e\u003cp\u003e\u003ci\u003eMaking Agile Native to Design Control\u003c\/i\u003e 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.\u003c\/p\u003e\u003cp\u003eThis 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.\u003c\/p\u003e\u003cp\u003e\u003cb\u003eInside you'll find: \u003c\/b\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eThe Regulated Sprint Framework mapped to FDA QMSR, EU MDR, and ISO 13485\u003c\/li\u003e\n\u003cli\u003eSprint-level integration of ISO 14971 risk files, SOUP management, and design traceability\u003c\/li\u003e\n\u003cli\u003ePCCP (Predetermined Change Control Plan) planning for AI\/ML SaMD\u003c\/li\u003e\n\u003cli\u003ePractical RACI matrices, SOPs, and design control templates ready for inspection\u003c\/li\u003e\n\u003cli\u003eEU MDR GSPR compliance crosswalks and PRRC accountability structures\u003c\/li\u003e\n\u003cli\u003eReal-world 483 patterns and how sprint-native design control prevents them\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eWhether 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.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Devin Mack\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798994787700\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Enqual LLC\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 03\/01\/2026\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 404\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.19lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 0.83d","brand":"Devin Mack","offers":[{"title":"Paperback","offer_id":49097269510399,"sku":"9798994787700","price":83.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.whiterainbookhouse.com\/products\/making-agile-native-to-design-devin-mack-9798994787700","provider":"WR Book House","version":"1.0","type":"link"}