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portada Medical Device Software Lifecycle in Practice: From Clinical Need Through Engineering, FDA Submission, Commercial Release, and Postmarket Stewardship
Type
Physical Book
Publisher
Author
Language
English
Pages
494
Format
Paperback
ISBN13
9798174841659

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

Gang Cheng (Author) · Independently Published · Paperback

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

New Book Imported to New Zealand
Delivery: 18 Nov - 25 Nov Shipping: 5 to 6 business days.
NZ$ 70.08
Import costs and 15% GST included in the price ✅
NZ$ 70.08

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

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. Read more

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