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RAC Practice Exam Questions and
Answers Latest 2026
All of the following are goals of PIC/S EXCEPT:
o A) Mutual recognition of inspections
o B) Publication of aide-memories for medical device
inspections
o C) Harmonization of GMP requirements
o D) Training of inspectors Ans: Answer: Publication of
aide-memories for medical devices inspections
The PIC scheme does not cover medical devices.
Regulatory Reference: PIC/S 1/95 (Rev. 4)
According to GHTF, key definitions and concepts for
clinical evidence including the following, EXCEPT:
o A) Clinical investigation is any systematic investigation
or study in or on one or more human subjects,
undertaken to assess the safety and/or performance of a
medical device
o B) A clinical investigation does not include feasibility
studies and is limited to studies conducted for the
purpose of gaining market approval or investigations
conducted following marketing approval.
© 2025 All rights reserved
RAC Practice Exam Questions and
Answers Latest 2026
All of the following are goals of PIC/S EXCEPT:
o A) Mutual recognition of inspections
o B) Publication of aide-memories for medical device
inspections
o C) Harmonization of GMP requirements
o D) Training of inspectors Ans: Answer: Publication of
aide-memories for medical devices inspections
The PIC scheme does not cover medical devices.
Regulatory Reference: PIC/S 1/95 (Rev. 4)
According to GHTF, key definitions and concepts for
clinical evidence including the following, EXCEPT:
o A) Clinical investigation is any systematic investigation
or study in or on one or more human subjects,
undertaken to assess the safety and/or performance of a
medical device
o B) A clinical investigation does not include feasibility
studies and is limited to studies conducted for the
purpose of gaining market approval or investigations
conducted following marketing approval.
© 2025 All rights reserved
