Free RAPS RAC-GS Exam Dumps Questions & Answers

Which of the following is NOT required to be included in a marketing application?

• A.  Quality, safety, and efficacy Information
• B.  Evidence of fee payment
• C.  Final printed label
• D.  Administrative forms

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

• A.  Local reimbursement requirements
• B.  Training program for sales people
• C.  Written procedure for product traceability
• D.  Service operation procedures

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

• A.  Adverse event caused by patient conditions
• B.  Malfunction occurring before the end of service life of the medical device
• C.  Malfunction protection operated correctly
• D.  Deficiency of a device found by the user prior to patient use

Which question is pertinent to demonstrate a new pharmaceutical's effectiveness during evaluation by a reimbursement agency?

• A.  "Is the product an established gold standard?"
• B.  "Is the product better than currently available alternatives?"
• C.  "Has the product been approved for mor&4nan 10 years?"
• D.  "Is the product profitable for the manufacturer?"

A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

• A.  Concept development and validation
• B.  Concept development and early technical design
• C.  Early technical design and product release
• D.  Product release and validation