ISO 14791 Definition

ISO 14971 and ISO 13485 are both critical standards in the medical device industry, but they serve different purposes.

• ISO 14971 outlines a structured approach to risk management for medical devices. This standard applies throughout the product lifecycle to ensure safety and compliance. It guides manufacturers in establishing a systematic approach to risk assessment, ensuring that potential hazards are mitigated to protect patient and user safety.

• ISO 13485 is a quality management system (QMS) standard that establishes requirements for organizations working with medical devices. It covers design, development, production, and servicing. It focuses on regulatory compliance, process control, and documentation to ensure product consistency and quality.

Although ISO 14971 is a standalone risk management standard, it’s closely linked to ISO 13485. That standard requires medical device manufacturers to incorporate risk-based decision-making into their quality management processes. This approach aligns with the principles ISO 14971 outlines. Many organizations incorporate ISO 14971 into their ISO 13485-compliant QMS to enhance risk management. This integration helps maintain overall regulatory compliance.

The most recent version, ISO 14971:2019, introduced key updates, including:

• Stronger emphasis on risk-benefit analysis.

• Clarifications on risk management throughout the product lifecycle.

• Additional guidance on production and post-production activities.

• Enhanced alignment with regulatory expectations from authorities like the FDA and EU MDR.

ISO 14971 and Failure Modes and Effects Analysis (FMEA) are both essential for managing risk in medical device development. However, they differ in scope and application.

• ISO 14971 defines a structured risk management approach for medical devices. It guides manufacturers in identifying, assessing, controlling, and monitoring risks across the product lifecycle. This standard addresses every stage of risk management, from hazard identification and risk estimation to control measures, residual risk evaluation, and post-market surveillance.

• FMEA is a risk assessment tool used within the broader ISO 14971 framework. It first identifies potential failure modes in a product, process, or system. Then, it evaluates their root causes, possible effects, and necessary measures to mitigate risks. FMEA is widely used to identify design or process weaknesses and proactively improve reliability.

FMEA is often used within an ISO 14971 risk management system as a risk assessment tool for specific product components or processes. While FMEA focuses on identifying and ranking failure modes, ISO 14971 takes a broader approach. It includes factors such as risk acceptability, risk-benefit analysis, and risk controls beyond failure mode analysis.