Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.

Abstract

This scoping review examines the implementation of Lean, Agile and hybrid Lean-Agile approaches in contexts relevant to the US Food and Drug Administration (FDA) and regulated medical devices. The review assesses whether these approaches can facilitate faster development while ensuring the integrity of lifecycle evidence, regulatory compliance and safety. The focus is on digital QMS, documentation, validation, design controls, and critical adoption barriers and enablers. A PRISMA-ScR aligned sco