What does ISO 13485 address in relation to medical devices?

• A. Marketing and advertising compliance
• B. Design, manufacture, installation, and servicing of medical devices
• C. Financial auditing standards
• D. Environmental health and safety only

Answer: (B)

ISO 13485 sets the requirements for a quality management system used by organizations that design, manufacture, install, and service medical devices. It focuses on ensuring that devices consistently meet regulatory and customer requirements throughout their lifecycle, from design and development through production, installation, servicing, and post-market activities. The emphasis is on process control, risk management, documentation, and traceability to prove safety and effectiveness. This standard isn’t about marketing and advertising, financial auditing, or environmental health and safety in isolation—the lifecycle approach to quality for medical devices is what it covers. The option describing design, manufacture, installation, and servicing best matches what ISO 13485 addresses.