Process validation and operational efficiency are two key elements in the medical industry. This article presents the case of the validation of three pieces of equipment used in the extrusion hose production process at a medical device manufacturer. The company faces operational and equipment validation challenges, which have led to inefficiency values up to 50.20% and a quality level below the 90% standard. One of the main problems is Poor Weld MASK defects, with 47 cases; failed EOL test, with 40 cases; and Broken Wire HUM, with 32 cases. The objective of this project is to increase operational efficiency and validate the equipment. To this end, the following four-phase method was implemented: Phase 1: Initial diagnosis; Phase 2: Application of Lean Manufacturing tools; Phase 3: Formal validation of equipment; and Phase 4: Monitoring and continuous improvement system. Lean Manufacturing tools such as 5S, Value Stream Mapping, Kaizen, and SMED were applied in each phase. As a result, the equipment was validated with CPk values of 1.45, 1.05, and a rejection rate of less than 10%. In addition, operational inefficiency was reduced, reaching values of 16.70% to 18.10%. The percentage of defects was reduced from 14.47% to 3.79%, EOL was reduced by 71.72%, and USW by 63.16%, improving the quality indicator from 70% to 82.7%. Cycle times were reduced in all areas. This leads to the conclusion that lean manufacturing tools are an efficient instrument for validating equipment and increasing the operational efficiency of a production process.