Medical Device Software Lifecycle in Practice: From Clinical Need Through Engineering, FDA Submission, Commercial Release, and Postmarket Stewardship - Softcover

Cheng, Dr. Gang

9798174841659: Medical Device Software Lifecycle in Practice: From Clinical Need Through Engineering, FDA Submission, Commercial Release, and Postmarket Stewardship

Softcover

ISBN 13: 9798174841659

Publisher: Independently published, 2026

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Medical-device software is not just code—and completing every lifecycle activity does not guarantee that the finished product is ready for clinical use.

Medical 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 devices.

Using 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 retirement.

Its 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.

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