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  • The ASQ Certified Medical Device Auditor Handbook by Scott A. Laman book cover
  • The ASQ Certified Medical Device Auditor Handbook by Scott A. Laman book cover
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The ASQ Certified Medical Device Auditor Handbook

by Scott A. Laman

A structured reference for medical device auditing

$139.78 USD
$174.73 USD $139.78 USD
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AlbakiReads Editorial

A structured reference for medical device auditing

The fourth edition organizes medical device auditing material around the 2020 Certified Medical Device Auditor exam Body of Knowledge and reference list. Alongside exam preparation, it brings together topics relevant to quality systems and regulatory work, including data privacy and integrity, MDSAP, risk management, labeling, validation, human factors, usability engineering, and cybersecurity. A substantial section on quality tools and techniques adds practical methods to the handbook’s broader coverage. The publisher describes it as a resource to combine with other references for a wider grounding in the field.

Good fit for readers who enjoy

  • Candidates preparing for the Certified Medical Device Auditor exam
  • Medical device quality and auditing professionals seeking a topic-organized reference
  • Readers looking for coverage of quality tools alongside regulatory and technical subjects

Themes

Medical device auditingQuality systems and toolsRegulation and complianceRisk management and safetyData integrity and cybersecurity

Based on publisher information and book metadata.

Book overview

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 regulations
  • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations
  • A thorough explanation of quality tools and techniques
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