Features of adapting Lean manufacturing methodology to the requirements of the ISO 13485 standard

The article explores how Lean manufacturing methodology can be effectively adapted to meet the regulatory requirements of ISO 13485 in medical device production. The article used a structured narrative literature review of recent peer-reviewed studies published between 2021 and 2025, examining evidence from case studies, expert interviews, systematic reviews, and technology-focused investigations relevant to Lean, risk management, validation, documentation, and digitalisation in regulated environments. The review brings together a set of recurring features that appear to be essential when Lean is applied within an ISO 13485 quality system. One consistent theme is the need to build documentation and traceability requirements directly into Lean routines rather than managing them separately. Another is the limitation of relying solely on FMEA; the broader risk framework set out in ISO 14971 has to be reflected in improvement work. This point, along with the others identified in the review, should be of practical use to teams involved in Lean work within medical-device manufacturing, particularly where operations and quality or regulatory staff have to plan improvements together. The material may also give researchers a more concrete basis for examining the ways Lean methods intersect with ISO 13485 and where the existing models still fall short.