Sterile medical devices are directly linked to patient health and safety; consequently, the GMP-compliant design of their production workshops serves as the fundamental basis for product quality control and is a mandatory prerequisite for regulatory compliance and successful inspection. Unlike standard cleanrooms, the design of GMP workshops for sterile medical devices prioritizes contamination control, risk alignment, and end-to-end process control. By utilizing a turnkey cleanroom solution, enterprises can achieve the integrated implementation of materials, equipment, and construction, ensuring a balance of safety, regulatory compliance, and operational practicality.