The new 4th edition of the Certified Medical Device Auditor Handbook, H1572, has been published. I got my copy today.
Part I on Auditing contains new content on Data Privacy, Data Integrity Principles, and the Medical Device Single Audit Program (MDSAP).
Part II on Medical Device Quality Management System Requirements contains an entirely new Chapter 6, as the subject of “The EU Medical Device Regulation” has replaced “The EU Medical Device Directives.” Chapters 4 and 5 have been switched in order to be consistent with the sequencing in the 2020 BoK. Chapter 4 has been rewritten and enhanced with new content on various Codes of Federal Regulations that were not in the 3rd edition. Chapter 8 on In Vitro Diagnostic (IVD) devices has also been substantially rewritten.
Part III on Technical Medical Device Knowledge contains new chapters 13 (Human Factors and Usability Engineering), 16 (General Safety and Performance Requirements, 18 (Labeling), and 22 (Validation). Chapter 12 (Risk Management) has been rewritten to cover ISO 14971:2019 and the risk management requirements in IEC 62366 for usability engineering and ISO 13485 for quality system risk management. Chapter 17 (Software Development and Maintenance for Products) has been rewritten with additional content on the applicable guidances as well as cybersecurity considerations.
Part IV on Quality Tools and Techniques has been improved with additional details and explanations. New content includes Five (5) Whys, Is/Is Not (Kepner-Tregoe), Setting Alert and Action Limits, Levels of Measurement, and Sampling. A related subject, Test Method Validation and Measurement Systems Analysis, is covered in Chapter 22 as part of Validation.