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Exam Code: RAC-GS
Exam Name: Regulatory Affairs Certification (RAC) Global Scope
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New RAC-GS Test Pass4Sure Total Q&A: 100 Questions and Answers
Last Update: 2017-05-19

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Exam Code: RAC-US
Exam Name: Regulatory Affairs Certification (RAC) US
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RAC-US Reliable Test Voucher Total Q&A: 100 Questions and Answers
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NO.1 During the review of a design dossier, the reviewer asks why the company has only carried out
a top-down risk approach. The reviewer is referring to which of the following?
A. Failure mode and effect analysis
B. Fault tree analysis
C. Hazard and operability study
D. ISO 14971 risk analysis
Answer: D

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NO.2 A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become
involved?
A. Concept development and early technical design
B. Early technical design and product release
C. Product release and validation
D. Concept development and validation
Answer: A

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Posted 2017/5/20 10:24:19  |  Category: RAPS  |  Tag: New RAC-GS Test Pass4SureRAC-US Reliable Test VoucherRAPS
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