Design Validation and Verification

Design verification and validation are processes that ensure a product meets its design requirements and user needs. They are important parts of the development process for medical devices and other products.

Design verification

• Confirms that a product’s design meets its specifications
• Ensures that the product was built correctly
• Involves testing, inspections, and reviewing design documents

Design validation

• Confirms that a product meets the needs of its users
• Ensures that the product is safe and effective for its intended use
• Involves testing in real-world settings, such as clinical studies and field trials

How they work together

• Design verification and validation work together to ensure product quality and compliance
• They are formal parts of design control requirements for medical device development regulations and standards