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NEW QUESTION 25
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

• A. Inform the company's senior management and arrange an emergency meeting
• B. Consult with the company's legal department regarding options.
• C. Arrange for additional testing of the product at the testing facility.
• D. Obtain a copy of the proposed regulation and analyze the impact.

Answer: D

NEW QUESTION 26
A company is developing a line of products for which no ISO standard of performance is available. As a result, the company wishes to propose developing such a standard. Whom should the company contact in order to start the development of the new standard?

• A. The ISO national member body
• B. The ISO Secretariat
• C. The country's regulatory authority
• D. The ISO technical committee in charge of the area

Answer: A

NEW QUESTION 27
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

Answer: D

NEW QUESTION 28
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