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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. No action is needed in this situation.
B. Write a memo to file since the change does not impact product safety and effectiveness.
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
An IT organization wishes to adopt ITaaS to offer services to customers. What should the organization consider when designing services?
A. Ensure that each service has dedicated resources available all the time in the resource pool
B. Use different service template for different business units to design all the services to be offered
C. Ensure services are tightly coupled so that each service operates effectively
D. Manage the entire service lifecycle with the goal of zero-touch orchestration and service installation
Answer: B

NEW QUESTION: 3
どのISO / IEC規格セットが、人員配置と公式の役割のクラウド定義を文書化していますか？
応答：
A. ISO / IEC 27001
B. ISO / IEC 17789
C. ISO / IEC 17788
D. ISO / IEC 27040
Answer: C