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Reference text on validation processes for manufacturing medical devices.
Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.
HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
At over 200 pages, this pocket book will bring you up to speed quickly on the requirements of process validation. It is divided into logical chapters that sets out the journey of validation in a clear fashion. Many components of Validation for medical devices are transferable. Understanding the fundamental principles of validation allows the reader to apply them to different products and different manufacturing processes. This book is ideal for professionals new to Process Validation. Although it has a practical approach, it is also suited to the academic. Chapter 1: Validation Planning, Chapter 2: Facilities And Utilities Qualification Chapter 3: Equipment And Software Validation Chapter 4: Process Validation Chapter 5: Packaging Validation Chapter 6: Test Method Validation Chapter 7: Measurement Chapter 8: ISO 13485 Chapter 9: Lean
Validation is a regulatory and legal requirement for the manufacture of medical devices and medicinal products. Validation is concerned with ensuring design requirements are fulfilled and that products are safely and consistently manufactured. It is a systematic and logical process. This book provides a concise overview and reference for engineers. It includes chapters on equipment and process validation and test method validation. Ancillary services and facilities are also reviewed in terms of typical deliverables.
This concise book fits right in the Engineers pocket. It provides a brief introduction to Test method validation and is a useful resource that defines key terms and concepts. The following points are addressed: Examples of Test Method Validations What is test method validation? Why should TMV be performed? When should methods be validated? Regulatory Overview US Food and Drug Administration W.H.O ISO 13485 Definitions and Key Concepts New Test Methods Changes to Existing Methods Accuracy Precision Ruggedness Representative/Continuous Sampling Range Resolution Probability Of False Alarms P (Fa) Probability Of Misses P (M) Validation Protocols What Can Impact the Accuracy of a Test Method? General MSA requirements Variable MSA Studies Attribute MSA Studies Measurement Capability Index