Page 1 of 48
RAPS ACTUAL PRACTICE EXAM NEWEST 2026/2027 COMPLETE
QUESTIONS AND CORRECT ANSWERS ALREADY GRADED
A+||BRAND NEW PDF!!
A company is submitting a PMA for a permanent implant. The company has performed
biocompatibility testing based on ISO requirements and believes the package is complete.
Which of the following testing does the company absolutely need to demonstrate long-term
safety of its device:
A. Intracutaneous irritation
B. Genotoxicity
C. Acute toxicity
D. Carcinogenicity - CORRECT ANSWER D. Carcinogenicity
A device that has just received marketing approval outside the US is to be shipped from the
US to a foreign distributor of Company XYZ. Company XYZ contacts the foreign distributor,
who confirms the product has not yet been shipped and is still at its warehouse. Company
XYZ requests the foreign distributor return the device immediately. This activity described is
an example of a:
A. Market withdrawal
B. Stock recovery
C. Class I recall
D. Class III recall - CORRECT ANSWER B. Stock recovery
,Page 2 of 48
All of the following are considered raw data in a preclinical study EXCEPT:
A. Final Pathology Report
B. Records of quarantine and animal receipt
C. Animal data entered into animal chart
D. Computer printout derived from data transferred to computer media from lab data sheets
- CORRECT ANSWER D. Computer printout derived from data transferred to computer
media from lab data sheets
Your Notified Body is classifying your device differently from you assessment. After
reviewing the classification rules, you are certain your classification is correct; however, the
Notified Body is not willing to reconsider. What is the BEST strategy to resolve this
situation?
A. Change Notified Body
B. Discuss with the Notified Body the reasons for your opinion
C. Ask the Notified Body to get an opinion from its Competent Authority
D. Sign the Declaration of Conformity and CE mark your device
- CORRECT ANSWER C. Ask the Notified Body to get an opinion from its Competent
Authority
The Clinical Investigation Plan (CIP) must include:
,Page 3 of 48
A. A clinical investigator's brochure
B. A clinical investigation protocol
C. The clinical investigator's qualifications
D. A copy of the informed consent form - CORRECT ANSWER B. A clinical investigation
protocol
The marketing department asks your opinion regarding shelf-life labelling for a new medical
device to be able to place it on the market as soon as possible. Which of the following
should you advise the marketing department to do?
A. Do not put a "use-by" date on the device
B. Perform prospective accelerated aging studies for the minimum time periods customers
will accept
C. Label as they see fit, to be followed by retrospective studies using real time experience
D. Find out what shelf life is used by the competition - CORRECT ANSWER B. Perform
prospective accelerated aging studies for the minimum time periods customers will
accept
A clinical trial of a medical device can begin how many days after notification is sent to the
Competent Authority?
A. 30 days
B. 45 days
C. 60 days
, Page 4 of 48
D. As soon as Ethical Committee approval is received - CORRECT ANSWER C. 60 days
A company is performing routine site monitoring of its pivotal clinical study for a blood sugar
meter and finds one site has not consented 1/3 of its subjects properly. What is the FIRST
thing the company needs to do?
A. Stop the entire study
B. Inform FDA and ask for guidance
C. Re-train the study staff, including the principle investigator at that site on
GCP
D. Re-consent all improperly consented subjects - CORRECT ANSWER D. Re-consent all
improperly consented subjects
The quality assurance manager of a small company with 12 employees is the company's
only internal auditor and has been performing all internal quality system audits for three
years. This does not meet the requirements for performing internal quality systems audits
because:
A. Auditor independence has not been ensured
B. There is no one in the company qualified to train the quality assurance manager in
quality auditing principles
C. Quality system audits cannot be performed by the same auditor for more than two audits
in a row
RAPS ACTUAL PRACTICE EXAM NEWEST 2026/2027 COMPLETE
QUESTIONS AND CORRECT ANSWERS ALREADY GRADED
A+||BRAND NEW PDF!!
A company is submitting a PMA for a permanent implant. The company has performed
biocompatibility testing based on ISO requirements and believes the package is complete.
Which of the following testing does the company absolutely need to demonstrate long-term
safety of its device:
A. Intracutaneous irritation
B. Genotoxicity
C. Acute toxicity
D. Carcinogenicity - CORRECT ANSWER D. Carcinogenicity
A device that has just received marketing approval outside the US is to be shipped from the
US to a foreign distributor of Company XYZ. Company XYZ contacts the foreign distributor,
who confirms the product has not yet been shipped and is still at its warehouse. Company
XYZ requests the foreign distributor return the device immediately. This activity described is
an example of a:
A. Market withdrawal
B. Stock recovery
C. Class I recall
D. Class III recall - CORRECT ANSWER B. Stock recovery
,Page 2 of 48
All of the following are considered raw data in a preclinical study EXCEPT:
A. Final Pathology Report
B. Records of quarantine and animal receipt
C. Animal data entered into animal chart
D. Computer printout derived from data transferred to computer media from lab data sheets
- CORRECT ANSWER D. Computer printout derived from data transferred to computer
media from lab data sheets
Your Notified Body is classifying your device differently from you assessment. After
reviewing the classification rules, you are certain your classification is correct; however, the
Notified Body is not willing to reconsider. What is the BEST strategy to resolve this
situation?
A. Change Notified Body
B. Discuss with the Notified Body the reasons for your opinion
C. Ask the Notified Body to get an opinion from its Competent Authority
D. Sign the Declaration of Conformity and CE mark your device
- CORRECT ANSWER C. Ask the Notified Body to get an opinion from its Competent
Authority
The Clinical Investigation Plan (CIP) must include:
,Page 3 of 48
A. A clinical investigator's brochure
B. A clinical investigation protocol
C. The clinical investigator's qualifications
D. A copy of the informed consent form - CORRECT ANSWER B. A clinical investigation
protocol
The marketing department asks your opinion regarding shelf-life labelling for a new medical
device to be able to place it on the market as soon as possible. Which of the following
should you advise the marketing department to do?
A. Do not put a "use-by" date on the device
B. Perform prospective accelerated aging studies for the minimum time periods customers
will accept
C. Label as they see fit, to be followed by retrospective studies using real time experience
D. Find out what shelf life is used by the competition - CORRECT ANSWER B. Perform
prospective accelerated aging studies for the minimum time periods customers will
accept
A clinical trial of a medical device can begin how many days after notification is sent to the
Competent Authority?
A. 30 days
B. 45 days
C. 60 days
, Page 4 of 48
D. As soon as Ethical Committee approval is received - CORRECT ANSWER C. 60 days
A company is performing routine site monitoring of its pivotal clinical study for a blood sugar
meter and finds one site has not consented 1/3 of its subjects properly. What is the FIRST
thing the company needs to do?
A. Stop the entire study
B. Inform FDA and ask for guidance
C. Re-train the study staff, including the principle investigator at that site on
GCP
D. Re-consent all improperly consented subjects - CORRECT ANSWER D. Re-consent all
improperly consented subjects
The quality assurance manager of a small company with 12 employees is the company's
only internal auditor and has been performing all internal quality system audits for three
years. This does not meet the requirements for performing internal quality systems audits
because:
A. Auditor independence has not been ensured
B. There is no one in the company qualified to train the quality assurance manager in
quality auditing principles
C. Quality system audits cannot be performed by the same auditor for more than two audits
in a row
