The ASQ Certified Medical Device Auditor Handbook
- Indbinding:
- Hardback
- Sideantal:
- 374
- Udgivet:
- 5. februar 2021
- Størrelse:
- 178x254x22 mm.
- Vægt:
- 862 g.
- 8-11 hverdage.
- 6. december 2024
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Abonnementspris
- Rabat på køb af fysiske bøger
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
Beskrivelse af The ASQ Certified Medical Device Auditor Handbook
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 regulationsNew content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerationsA thorough explanation of quality tools and techniques
A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP)Current information about federal and international regulationsNew content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerationsA thorough explanation of quality tools and techniques
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