The ASQ Certified Medical Device Auditor Handbook
eBook - ePub

The ASQ Certified Medical Device Auditor Handbook

  1. 372 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

The ASQ Certified Medical Device Auditor Handbook

About this book

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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Yes, you can access The ASQ Certified Medical Device Auditor Handbook by Scott A. Laman in PDF and/or ePUB format, as well as other popular books in Business & Auditing. We have over one million books available in our catalogue for you to explore.

Information

Year
2021
Print ISBN
9781951058357
eBook ISBN
9781953079978
Edition
4
Subtopic
Auditing

Table of contents

  1. Cover
  2. Title page
  3. CIP data
  4. Acknowledgments
  5. Part I: Auditing
  6. Part II: Medical Device Quality Management System Requirements
  7. Part III: Technical Medical Device Knowledge
  8. Part IV: Quality Tools and Techniques
  9. Part V: Appendices
  10. Endnotes
  11. About the Editor