Medical Device Software Lifecycle in Practice : From Clinical Need Through Engineering, FDA Submission, Commercial Release, and Postmarket Stewardship
Language: English
Published by Independently Published Sep 2026, 2026
- Softcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 38.57
Quantity: 2 available
Add to basketItem description from seller
Neuware - 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. …
Seller Inventory # 9798174841659
- Title
- Medical Device Software Lifecycle in Practice : From Clinical Need Through Engineering, FDA Submission, Commercial Release, and Postmarket Stewardship
- Author
- Gang Cheng
- Publisher
- Independently Published Sep 2026
- Publication year
- 2026
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 13
- 9798174841659
- Item weight
- 850 grams
- Dimensions
- 254x178x25 mm
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.
"Synopsis" may belong to another edition of this title.
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| Item | 7 to 10 business days | 5 to 7 business days |
|---|---|---|
| First item | £ 29.57 | £ 38.02 |
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