Medical Device Software Lifecycle in Practice: From Clinical Need Through Engine

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Medical Device Software Lifecycle in Practice by Gang Cheng

Medical-device software is not just code-and completing every lifecycle activity does not guarantee that the finished product is ready for clinical Device Software Lifecycle in Practice is a practical desk reference for software engineers, architects, technical leads, engineering managers, systems engineers, and quality and regulatory professionals working with software-intensive medical three fictional reference products-embedded imaging-control software, AI-enabled diabetic-retinopathy screening software, and a cloud-connected clinical management application-the book follows the complete lifecycle from clinical need and intended use through regulatory strategy, risk management, requirements, architecture, implementation, verification, validation, FDA submission, design transfer, release, launch, maintenance, CAPA, cybersecurity response, controlled change, migration, and central theme is the Evidence Chain: keeping claims, requirements, risk controls, configurations, objective evidence, regulatory commitments, release decisions, and field learning connected so that they continue to describe the same product throughout its life.

FORMAT
Paperback CONDITION
Brand New Details ISBN Author Gang Cheng Pages 494 Publisher Independently Published Year 2026 ISBN-13 9798174841659 Format Paperback Publication Date 2026-09-20 Imprint Independently Published Subtitle From Clinical Need Through Engineering, FDA Submission, Commercial Release, and Postmarket Stewardship Audience General Country of Origin US Product Class Description Medical Nursing & Ancillary Services
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