The ASQ Certified Medical Device Auditor Handbook

<p><span style=color: rgba(51 51 51 1)>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:</span></p><ul><li><span style=color: rgba(51 51 51 1)> A discussion of data privacy data integrity principles and the Medical Device Single Audit Program (MDSAP)</span></li><li><span style=color: rgba(51 51 51 1)>Current information about federal and international regulations</span></li><li><span style=color: rgba(51 51 51 1)>New content regarding human factors and usability engineering general safety and performance requirements labeling validation risk management and cybersecurity considerations</span></li><li><span style=color: rgba(51 51 51 1)>A thorough explanation of quality tools and techniques</span></li></ul>