Glossary Term
Acceptance Criteria
Definition
Acceptance Criteria are predefined requirements or specifications that a medical device, its components, or associated processes must meet to be deemed acceptable for its intended use. These criteria, established during design and development, testing, and validation phases, serve as benchmarks for evaluating conformance to safety, performance, and quality standards.
Relevance to the MedTech Industry
Acceptance Criteria ensure medical devices consistently meet regulatory, safety, and quality standards. By defining measurable thresholds for performance, usability, and risk management, these criteria guide design, manufacturing, and quality assurance processes, supporting compliance with frameworks like ISO 13485 and FDA’s Quality System Regulation (QSR).
Additional Information & Related Terms
Design Validation Ensures the device meets user needs and intended use.
Process Validation Confirms manufacturing processes consistently meet criteria.
Nonconformance Report (NCR) Documents instances where Acceptance Criteria are not met.
Risk Management File (ISO 14971) Incorporates Acceptance Criteria into risk assessments.