PDF book library free download

The Medical Device Industry

The Medical Device Industry PDF
Author: Norman F. Estrin
Publisher: CRC Press
ISBN: 9780824782689
Size: 34.24 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 976
View: 5534

Get Book


Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach

Design Controls For The Medical Device Industry Third Edition

Design Controls for the Medical Device Industry  Third Edition PDF
Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 1351261460
Size: 59.96 MB
Format: PDF
Category : Medical
Languages : en
Pages : 248
View: 2728

Get Book


This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements

Design Controls For The Medical Device Industry

Design Controls for the Medical Device Industry PDF
Author: Marie Teixeira
Publisher: CRC Press
ISBN: 9780203909386
Size: 62.23 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 254
View: 1516

Get Book


This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

Proactive Supplier Management In The Medical Device Industry

Proactive Supplier Management in the Medical Device Industry PDF
Author: James B. Shore
Publisher: Quality Press
ISBN: 0873899318
Size: 10.63 MB
Format: PDF, Kindle
Category : Business & Economics
Languages : en
Pages : 144
View: 6687

Get Book


In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect. The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors. In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world. Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether it’s a requirement or a tool to help achieve compliance. The “Lessons from the Road” icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.

The Medical Device Industry

The Medical Device Industry PDF
Author: John Burton
Publisher: Cambridge Scholars Publishing
ISBN: 1443808393
Size: 47.97 MB
Format: PDF, ePub
Category : Law
Languages : en
Pages : 200
View: 3033

Get Book


The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.

Fda And The Medical Device Industry

FDA and the Medical Device Industry PDF
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Size: 57.25 MB
Format: PDF, ePub, Mobi
Category : Heart valve prosthesis industry
Languages : en
Pages : 626
View: 7084

Get Book



Design Controls For The Medical Device Industry Second Edition

Design Controls for the Medical Device Industry  Second Edition PDF
Author: Marie B. Teixeira
Publisher: CRC Press
ISBN: 1466503556
Size: 79.64 MB
Format: PDF
Category : Medical
Languages : en
Pages : 205
View: 6085

Get Book


The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.