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Following is the prerequisite for the RAPS RAC-US Certification Exam:

  • You must be a member of RAPS, the Regulatory Affairs Professionals Society
  • You must have 3 to 5 years of experience in regulatory affairs.
  • You should have a Bachelor's degree or higher

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Naturally, you are eager to have an opportunity to become RAC-US certified, right? Well, it is because the RAC-US certification program is an excellent way for healthcare regulatory professionals to show that they are a leader in the regulatory field. It is also one of the most difficult regulatory exams in the world today. The RAC-US Certification represents the most competitive and rigorous professional certification in the healthcare sector. This is a must for all regulatory professionals who are looking for a path to advancement in their careers. They can get help from the RAC-US exam dumps to solve the exam. Board of trustees membership is not enough; if you want to be a leader in the industry, then you should be RAC-US certified.

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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q26-Q31):

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

Answer: B

Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

  • A. Initiate a global submission process after all submission data are finalized.
  • B. Plan regulatory approval update meetings with senior management and stakeholders.
  • C. Utilize the STED template to complete global requirements.
  • D. Identify countries where special requirements exist during the product development phase.

Answer: D

After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

  • A. Add a warning in the IFU.
  • B. Discontinue the project.
  • C. Perform another risk-benefit analysis.
  • D. Redesign the device.

Answer: D

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. Prepare regulatory submissions that detail the medical device's change in materials.
  • C. Review the content of change and supporting data for the equivalency with the current material.
  • D. Write a memo to file since the change does not impact product safety and effectiveness.

Answer: C

A company is developing a new medical device using innovative technology. Which of the following is MOST critical in working with regulatory authorities?

  • A. Follow-up meeting after submission
  • B. Documented agreement
  • C. Early collaboration
  • D. Frequent communication

Answer: D


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