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NEW QUESTION: 1
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.
Answer: C
NEW QUESTION: 2
Which permissions should be given to a file that needs to be opened and edited by the file's owner and opened read-only by the file's group?
A. 0444
B. 0751
C. 0640
D. 0540
E. 0466
Answer: C
NEW QUESTION: 3
DRAG DROP
Match each tool or technique to its corresponding Project Risk Management process. Click on the tool or technique on the left and drag it to the appropriate gray box in the middle.
Answer:
Explanation: