The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author:
Publisher: Asq Press
ISBN:
Format: PDF, Kindle
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This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DIS 13485:1996). Icons quickly establish the differences and relationship between FDA regulation, the ISO 9001 standard, FDA guidance, and the Global Harmonization Task Force (GHTF) guidance. In addition, the end of each subsection includes blank pages for your notes. This book allows manufacturers to establish a single quality system that satisfies world requirements.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel
Publisher: ASQ Quality Press
ISBN: 0873897404
Format: PDF, ePub, Mobi
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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

Design of Biomedical Devices and Systems 4th edition

Author: Paul H. King
Publisher: CRC Press
ISBN: 0429786050
Format: PDF, ePub
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This will be a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter will be thoroughly updated and revised to reflect the latest developments. New material will be added on entrepreneurship, bioengineering statistics, clinical trials and CRISPR. New examples, applications and problems will be added in each chapter.There will be strong efforts made to increase the number of clinical applications to enhance the overall relevance of the material that's presented. Significant new material added on FDA regulations.

Medical Device Quality Assurance and Regulatory Compliance

Author: Richard C. Fries
Publisher: CRC Press
ISBN: 148227003X
Format: PDF
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"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

FDA Regulatory Affairs

Author: David Mantus
Publisher: CRC Press
ISBN: 1841849197
Format: PDF, Kindle
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FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Author: José Rodríguez-Pérez
Publisher: ASQ Quality Press
ISBN: 0873898699
Format: PDF, Kindle
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This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.

Klassische Elektrodynamik

Author: John David Jackson
Publisher: Walter de Gruyter
ISBN: 311033447X
Format: PDF, ePub
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The German translation of this classic of theoretical physics is now available in a further revised edition. This renders theoretical electrodynamics even more comprehensible than before. Unique to this textbook of electrodynamics are the incomparably large number of calculated examples and special cases and the many exercises at the end of each chapter.