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Author: Itay Abuhav Publisher: CRC Press ISBN: 1351000772 Category : Medical Languages : en Pages : 735
Book Description
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author: Itay Abuhav Publisher: CRC Press ISBN: 1351000772 Category : Medical Languages : en Pages : 735
Book Description
Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author: Publisher: ISBN: Category : Information technology Languages : en Pages : 41
Book Description
ISO/IEC 15504 is an emerging international standard on software process assessment. It defines a number of software engineering processes and a scale for measuring their capacity. This paper describes an empirical study that investigates the relationship between the capability of the software development processes (namely design, coding, and integration & testing) as defined in the 15504 standard and the performance of software projects. Researchers conducted assessments using ISO/IEC 15504 on projects world-wide over a two-year period. Performance measures on each project, such as the ability to meet budget commitments and staff productivity, were also collected using questionnaires. The results provide evidence of the predictive validity for the development process capability measures used in ISO/IEC 15504 for large organizations.
Author: Anne Booth Publisher: CRC Press ISBN: 9781587160578 Category : Medical Languages : en Pages : 170
Book Description
The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Author: Mourad Debbabi Publisher: Springer Science & Business Media ISBN: 3642152287 Category : Computers Languages : en Pages : 261
Book Description
At the dawn of the 21st century and the information age, communication and c- puting power are becoming ever increasingly available, virtually pervading almost every aspect of modern socio-economical interactions. Consequently, the potential for realizing a signi?cantly greater number of technology-mediated activities has emerged. Indeed, many of our modern activity ?elds are heavily dependant upon various underlying systems and software-intensive platforms. Such technologies are commonly used in everyday activities such as commuting, traf?c control and m- agement, mobile computing, navigation, mobile communication. Thus, the correct function of the forenamed computing systems becomes a major concern. This is all the more important since, in spite of the numerous updates, patches and ?rmware revisions being constantly issued, newly discovered logical bugs in a wide range of modern software platforms (e. g. , operating systems) and software-intensive systems (e. g. , embedded systems) are just as frequently being reported. In addition, many of today’s products and services are presently being deployed in a highly competitive environment wherein a product or service is succeeding in most of the cases thanks to its quality to price ratio for a given set of features. Accordingly, a number of critical aspects have to be considered, such as the ab- ity to pack as many features as needed in a given product or service while c- currently maintaining high quality, reasonable price, and short time -to- market.
Author: Ronald Pilchik Publisher: CRC Press ISBN: 1420014943 Category : Medical Languages : en Pages : 158
Book Description
According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instruc
Author: R. D. McDowall Publisher: Royal Society of Chemistry ISBN: 9780854049691 Category : Computers Languages : en Pages : 306
Book Description
Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.
Author: Anne F Booth Publisher: CRC Press ISBN: 1351357573 Category : Medical Languages : en Pages : 170
Book Description
The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Author: Wesley M. Johnson Publisher: FriesenPress ISBN: 1460210271 Category : Science Languages : en Pages : 81
Book Description
The book introduces the new concepts of target measurement uncertainty and decision rules and explains how to use them to demonstrate a method is fit-for-purpose. As well, they can be used to set the acceptance criteria for a method validation clearly and quantitatively. Examples are given that illustrate the concepts so that the reader can easily apply decision rules and target measurement uncertainty to their methods. The book covers all aspects of method validation from stating the purpose of the method using a Decision Rule, calculating the target measurement uncertainty, deciding the required parameters that need to be included in the method validation, estimating the measurement uncertainty, and setting the acceptance criteria. With this approach the reader will fully understand the method, what its critical control points are and what to control and monitor during routine use. This approach fits in well with the lifecycle approach to analytical methods. The book covers the basics and advanced aspects of method validation so that it is useful for people new to method validation and those with experience. The book is applicable for laboratories in many industries, from mining to pharmaceutical manufacturing to food analysis....
Author: Jan Goyvaerts Publisher: "O'Reilly Media, Inc." ISBN: 1449327486 Category : Computers Languages : en Pages : 612
Book Description
Take the guesswork out of using regular expressions. With more than 140 practical recipes, this cookbook provides everything you need to solve a wide range of real-world problems. Novices will learn basic skills and tools, and programmers and experienced users will find a wealth of detail. Each recipe provides samples you can use right away. This revised edition covers the regular expression flavors used by C#, Java, JavaScript, Perl, PHP, Python, Ruby, and VB.NET. You’ll learn powerful new tricks, avoid flavor-specific gotchas, and save valuable time with this huge library of practical solutions. Learn regular expressions basics through a detailed tutorial Use code listings to implement regular expressions with your language of choice Understand how regular expressions differ from language to language Handle common user input with recipes for validation and formatting Find and manipulate words, special characters, and lines of text Detect integers, floating-point numbers, and other numerical formats Parse source code and process log files Use regular expressions in URLs, paths, and IP addresses Manipulate HTML, XML, and data exchange formats Discover little-known regular expression tricks and techniques
Author: Itay Abuhav
Author: Itay Abuhav
Author: 
Author: Anne Booth
Author: Mourad Debbabi
Author: Ronald Pilchik
Author: R. D. McDowall
Author: 
Author: Anne F Booth
Author: Wesley M. Johnson
Author: Jan Goyvaerts