CBAEN Practice Test

1Single Choice

According to the ASQ Certified Medical Device Auditor (CMDA) body of knowledge, what is the primary objective of a medical device audit?

A.To certify that a medical device manufacturer is compliant with all global regulations at once
B.To systematically and independently examine medical device processes and products to determine whether they conform to specified requirements and are effectively implemented
C.To grade the financial performance of a medical device organization against industry benchmarks
D.To replace regulatory inspections conducted by authorities such as the FDA and Notified Bodies

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