RAC-US 무료 덤프문제 온라인 액세스

시험코드:	RAC-US
시험이름:	Regulatory Affairs Certification (RAC) US
인증사:	RAPS
무료 덤프 문항수:	100
업로드 날짜:	2026-07-19

평점

100%

페이지 수: 1 / 20
총 100 문항

문제 1

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

A.Plan regulatory approval update meetings with senior management and stakeholders.
B.Utilize the STED template to complete global requirements.
C.Initiate a global submission process after all submission data are finalized.
D.Identify countries where special requirements exist during the product development phase.

문제 2

The manufacturer of an API was changed from Company X to Company Y during the late stage of a new drug development. Despite differences in the manufacturing processes of the companies, both APIs meet the current specifications. Which is the MOST appropriate information to include in the final submission documents?

A.The process information and the comparative analytical result of APIs from both companies
B.The process information and analytical result of Company X API
C.The process information and analytical result of Company Y API
D.Information deemed appropriate by the regulatory authority

문제 3

According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

A.Risk control
B.Risk analysis
C.Risk estimation
D.Risk management

문제 4

During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?

A.Contact the marketing department to recall the product.
B.Allow doctors to use the product for the off-label indication.
C.Communicate with the sales department to stop using the promotional materials.
D.Request that doctors stop using the product for the off-label indication.

문제 5

At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?