Medical Device Risk Management

Employ risk-based thinking. Set up a system for effectively aligning people, processes, and technology. Defects or discrepancies commonly go undiscovered until later in the production process or postmarket. Medical device risk management needs to start earlier and be performed in greater detail and at every stage of the product’s life cycle.

ISO 13485 focuses on integrating active risk management in quality processes. It includes documenting requirements and maintaining risk management records throughout the product’s life cycle. ISO 14971 applies to identifying and controlling risk with intended use, foreseeable misuse, and hazardous situations throughout the product’s life cycle. 

Every organization differs on risk management. Still, most risk management strategies include these principles: 

Identify risks early.

Include organizational goals and objectives.

Manage risk within context.

Involve stakeholders.

Clarify all roles and responsibilities.

Create a cycle of risk review.

Strive for continuous improvement.