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portada The ASQ Certified Medical Device Auditor Handbook
Type
Physical Book
Author
Publisher
Language
English
Pages
374
Format
Hardcover
Dimensions
25.4x17.8x2.2 cm
Weight
0.86 kg.
ISBN13
9781953079961
Edition No.
0004
Categories

The ASQ Certified Medical Device Auditor Handbook

Scott A. Laman (Author) · ASQ Quality Press · Hardcover

The ASQ Certified Medical Device Auditor Handbook - Laman, Scott A.

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Synopsis "The ASQ Certified Medical Device Auditor Handbook "

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP)Current information about federal and international regulationsNew content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerationsA thorough explanation of quality tools and techniques

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