CRAP Product Development & Compliance

Question 1

What is the first stage in product development?

Accepted Answer

Concept and feasibility

Answer

Market launch.

Answer

Post-market surveillance.

Answer

Label printing.

Question 2

Why is compliance important in product development?

Accepted Answer

Ensures regulatory approval and safety

Answer

Reduces sales.

Answer

Increases launch delays.

Answer

Eliminates legal requirements.

Question 3

Which document outlines product development phases?

Accepted Answer

Development plan

Answer

Inspection report.

Answer

Sales brochure.

Answer

Certificate of origin.

Question 4

What role does Quality Assurance (QA) play?

Accepted Answer

Ensures product quality and regulatory adherence

Answer

Delivers packages.

Answer

Develops marketing plans.

Answer

Handles shipping.

Question 5

What is design control?

Accepted Answer

Process of managing design and verification

Answer

Marketing slogan.

Answer

Production checklist.

Answer

Public relations outline.

Question 6

Which regulation is crucial for medical device development in the U.S.?

Accepted Answer

21 CFR Part 820

Answer

21 CFR Part 11

Answer

HIPAA

Answer

GDPR

Question 7

What does risk management address?

Accepted Answer

Product design safety and hazards

Answer

Sales growth.

Answer

User feedback collection.

Answer

Employee productivity.

Question 8

Which standard is used for risk management in medical devices?

Accepted Answer

ISO 14971

Answer

ISO 9001

Answer

ISO 14001

Answer

ISO 27001

Question 9

What is the objective of product lifecycle management (PLM)?

Accepted Answer

Manage product from design to retirement

Answer

Extend shelf life.

Answer

Control pricing models.

Answer

Create advertising.