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Equivalence and Noninferiority Tests for Quality, Manufacturing and Test Engineers - Bok av Scott Pardo - Inbunden

Equivalence and Noninferiority Tests for Quality, Manufacturing and Test Engineers - Bok av Scott Pardo - Inbunden

This book presents methods for using validation and verification test data to demonstrate equivalence and noninferiority in engineering and applied science. It covers numerous tests drawn from the author¿s more than 30 years of work in a range of industrial settings. The book provides computational formulas for the tests, methods to determine or justify sample sizes, and formulas to calculate power and operating characteristic curves. The methods are accessible using standard statistical software..

SEK 2581.00
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Phylogeny, Anatomy and Physiology of Ancient Fishes - Bok - Inbunden

Phylogeny, Anatomy and Physiology of Ancient Fishes - Bok - Inbunden

This book on ancient fishes unites the work of many specialists coming from different areas of biology. This volume includes a phylogenetic account of the cardiac outflow tract, and the particulars of the heart and circulation in lungfishes. The control of breathing and the lung-swim bladder issue is discussed. The developmental anatomy of the sturgeon gut and accounts of the gut structure in lungfishes and garfishes are also included. Biochemical and physiological aspects of the behavior of lungfishes..

SEK 2580.00
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Validation for Medical Device and Diagnostic Manufacturers - Bok av Carol V. (Toft Desain - Inbunden

Validation for Medical Device and Diagnostic Manufacturers - Bok av Carol V. (Toft Desain - Inbunden

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..

SEK 2851.00
1

Experimental Characterization of Advanced Composite Materials - Bok av Leif A. Carlsson - Inbunden

Experimental Characterization of Advanced Composite Materials - Bok av Leif A. Carlsson - Inbunden

This practical treatment of the best available methods for determining mechanical properties, thermal expansion coefficients, and fracture and strength data for composite materials presents processing techniques, specimen preparation, analyses of test methods, test procedures, and data reduction schemes; covers specific aspects of lamina testing and laminate responses; and examines composite durability issues. The Fourth Edition is revised to include major additions in processing of thermoset resins,..

SEK 2377.00
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Usability Testing of Medical Devices - Bok av Michael E. Wiklund P.E. - Inbunden

Usability Testing of Medical Devices - Bok av Michael E. Wiklund P.E. - Inbunden

Since publication of the first edition, the FDA and other organizations and agencies have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this second edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates include guidance pertaining to new FDA and IEC requirements, linking usability test tasks to risk analysis..

SEK 2191.00
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