The ASQ Certified Medical Device Auditor Handbook 4th Edition by Scott Laman 9781953079978 1953079970
Original price was: $50.00.$35.00Current price is: $35.00.
The ASQ Certified Medical Device Auditor Handbook 4th Edition by Scott Laman – Ebook PDF Instant Download/Delivery: 9781953079978, 1953079970
Full download The ASQ Certified Medical Device Auditor Handbook 4th Edition after payment
Product details:
ISBN 10: 1953079970
ISBN 13: 9781953079978
Author: Scott Laman
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
The ASQ Certified Medical Device Auditor Handbook 4th Table of contents:
Part I: Auditing
Chapter 1 Auditing Fundamentals
Chapter 2 Auditing and Inspection Processes
Chapter 3 Audit Procedural References
Part II: Medical Device Quality Management System Requirements
Chapter 4 FDA–Code of Federal Regulations (CFR) Title 21
Chapter 5 U.S. Requirements (FD&C Act, 201, 301-304, 501-502, 510, 513, 518, 522, 704)
Chapter 6 The EU Medical Device Regulation
Chapter 7 Other International Regulations
Chapter 8 Requirements for In Vitro Diagnostic (IVD) Devices
Chapter 9 International Standards for Quality Systems
Chapter 10 Quality System Regulation (QSR) Requirements
Chapter 11 Post-market Surveillance
Part III: Technical Medical Device Knowledge
Chapter 12 Risk Management
Chapter 13 Human Factors and Usability Engineering
Chapter 14 Biological Evaluation
Chapter 15 Packaging
Chapter 16 General Safety and Performance Requirements
Chapter 17 Software Development and Maintenance for Products
Chapter 18 Labeling
Chapter 19 Controlled Environments and Utility Systems
Chapter 20 Sterile Medical Devices
Chapter 21 Laboratory Testing and Failure Analysis
Chapter 22 Validation
Chapter 23 Reprocessing/Reuse and Cleaning of Medical Devices
Chapter 24 Common Medical Device Directives and Standards
Chapter 25 Sources for New and Evolving Standards
Part IV: Quality Tools and Techniques
Chapter 26 Quality Control and Problem-Solving Tools
Chapter 27 Process Improvement Techniques
Chapter 28 Data Types and Sampling
Part V: Appendices
Appendix A: Glossary of Terms
Appendix B: Certified Medical Device Auditor (CMDA) Body of Knowledge (2020) .
Appendix C: Certified Medical Device Auditor (CMDA) References (2020)
Endnotes
About the Editor
People also search for The ASQ Certified Medical Device Auditor Handbook 4th :
the asq certified medical device auditor handbook fourth edition pdf
the asq certified medical device auditor handbook fourth edition
the asq certified medical device auditor handbook pdf
asq certified quality auditor salary
is an asq certification valuable
Tags:
Scott Laman,Certified Medical,Device Auditor