Module 16 2022

Risk Management: Why? • Risk Management is integral to

ensure quality and safety of a product by design not by tests or by hope • Differentiates most critical product features related to safety/harm • Quantifies and determines acceptability of risk • Provides focus and priority for product development and lifecycle activities (such as V&V, CAPA, etc.) • Regulatory requirement ISO 13485 / 14971 / TR24971

Business Use Only 4