Free Access RAPS.RAC-GS.v2022-03-28.q35 Practice Test (Page 8)

Question 31

A company is currently marketing an implantable orthopedic medical device. The R&D department is
planning to change the material used for the implant. The R&D department states that the change does
not impact the safety and effectiveness of the product. What action should the regulatory affairs
professional take FIRST?

A.Write a memo to file since the change does not impact product safety and effectiveness.

B.No action is needed in this situation.

C.Review the content of change and supporting data for the equivalency with the current material.

D.Prepare regulatory submissions that detail the medical device's change in materials.

Question 32

A company is developing a new medical device using innovative technology. Which of the following is
MOST critical in working with regulatory authorities?

A.Early collaboration

B.Documented agreement

C.Follow-up meeting after submission

D.Frequent communication

Question 33

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the
vendors comply with GMP requirements?

A.Document and perform audits.

B.Request an inspection from a regulatory authority.

C.Request documentation from the sub-contractor.

D.Ask the vendor to take responsibility.

Question 34

Which of the following is an example of an acceptable statement for an advertisement of an approved
arthritis medication?

A."Product X is effective in all patients with arthritis."

B."Product X is a guaranteed cure for arthritis."

C."Product X is safe for arthritis and without side effects."

D."Product X is effective for the treatment of arthritis."

Question 35

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?

A.Deficiency of a device found by the user prior to patient use

B.Adverse event caused by patient conditions

C.Malfunction protection operated correctly

D.Malfunction occurring before the end of service life of the medical device

Other Version: 37RAPS.Braindumpspass.RAC-GS.v2021-11-08.by.merle.33q.pdf

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Question 32

Question 33

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Question 35

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