According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?

• A.3
• B.5
• C.15
• D.10

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According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

• A.Risk management
• B.Risk control
• C.Risk estimation
• D.Risk analysis

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

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

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Which of the following BEST describes the process of post-marketing surveillance for healthcare products?

• A.Systematic procedure to review experiences with the products in use
• B.Vigilance procedure to ensure the full traceability of the products
• C.Vigilance procedure to notify the regulatory authorities about serious incidents
• D.Systematic procedure to review published scientific journals

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In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?

• A.Efficacy and material
• B.Safety and efficacy
• C.Compatibility and safety
• D.Volume and material

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