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Medical Device Regulatory Practices
  • Language: en
  • Pages: 590

Medical Device Regulatory Practices

  • Type: Book
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  • Published: 2015-08-03
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  • Publisher: CRC Press

This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Kenya Gazette
  • Language: en
  • Pages: 60

Kenya Gazette

  • Type: Magazine
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  • Published: 2005-09-23
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  • Publisher: Unknown

The Kenya Gazette is an official publication of the government of the Republic of Kenya. It contains notices of new legislation, notices required to be published by law or policy as well as other announcements that are published for general public information. It is published every week, usually on Friday, with occasional releases of special or supplementary editions within the week.

Mission-Critical and Safety-Critical Systems Handbook
  • Language: en
  • Pages: 592

Mission-Critical and Safety-Critical Systems Handbook

  • Type: Book
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  • Published: 2009-11-19
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  • Publisher: Newnes

This handbook provides a consolidated, comprehensive information resource for engineers working with mission and safety critical systems. Principles, regulations, and processes common to all critical design projects are introduced in the opening chapters. Expert contributors then offer development models, process templates, and documentation guidelines from their own core critical applications fields: medical, aerospace, and military. Readers will gain in-depth knowledge of how to avoid common pitfalls and meet even the strictest certification standards. Particular emphasis is placed on best practices, design tradeoffs, and testing procedures. *Comprehensive coverage of all key concerns for designers of critical systems including standards compliance, verification and validation, and design tradeoffs *Real-world case studies contained within these pages provide insight from experience

Healthcare Technology Management – A Systematic Approach
  • Language: en
  • Pages: 543

Healthcare Technology Management – A Systematic Approach

  • Type: Book
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  • Published: 2017-01-06
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  • Publisher: CRC Press

Healthcare Technology Management: A Systematic Approach offers a comprehensive description of a method for providing safe and cost effective healthcare technology management (HTM). The approach is directed to enhancing the value (benefit in relation to cost) of the medical equipment assets of healthcare organizations to best support patients, clinicians and other care providers, as well as financial stakeholders. The authors propose a management model based on interlinked strategic and operational quality cycles which, when fully realized, delivers a comprehensive and transparent methodology for implementing a HTM programme throughout a healthcare organization. The approach proposes that HTM...

PN-EN 60601-2-25
  • Language: en

PN-EN 60601-2-25

  • Type: Book
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  • Published: 2016
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  • Publisher: Unknown

None

Customer Relationship Management
  • Language: en
  • Pages: 450

Customer Relationship Management

This book balances the behavioral and database aspects of customer relationship management, providing students with a comprehensive introduction to an often overlooked, but important aspect of marketing strategy. Baran and Galka deliver a book that helps students understand how an enhanced customer relationship strategy can differentiate an organization in a highly competitive marketplace. This edition has several new features: Updates that take into account the latest research and changes in organizational dynamics, business-to-business relationships, social media, database management, and technology advances that impact CRM New material on big data and the use of mobile technology An overh...

Design of Medical Electronic Devices
  • Language: en
  • Pages: 279

Design of Medical Electronic Devices

Acknowledgments -- Introduction -- 1 Proper Design of Power Subsystems in Medical Electronics -- 2 Fundamentals of Magnetic Resonance Imaging -- 3 Particle Accelerator Design -- 4 Sensor Characteristics -- 5 Data Acquisition -- 6 Noise and Interference Issues in Analog Circuits -- 7 Hardware Approach to Digital Signal Processing -- 8 Optical Sensors -- Index.

PN-EN 60601-1-2
  • Language: en

PN-EN 60601-1-2

  • Type: Book
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  • Published: 2015
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  • Publisher: Unknown

None

PN-EN 60601-2-5
  • Language: en

PN-EN 60601-2-5

  • Type: Book
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  • Published: 2016
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  • Publisher: Unknown

None

PN-EN 60601-2-16
  • Language: en

PN-EN 60601-2-16

  • Type: Book
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  • Published: 2015
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  • Publisher: Unknown

None