Infrastructure Set Up Solutions

Building a robust infrastructure for medical device manufacturing is essential for ensuring quality, compliance, and efficiency. The infrastructure must include well-designed buildings and workspaces that support various stages of manufacturing, from raw material storage to final product assembly. This includes cleanrooms, controlled environments, and specialized areas for different processes, reliable process equipment machinery for manufacturing, testing, and packaging medical devices, adequate utilities such as power, water, gas, and internet are essential. Supporting services like transportation mechanisms (e.g., conveyor belts, forklifts) and communication systems are also vital for smooth operations. Adhering to standards like ISO 13485:2016 and ISO 14644-1 guidelines for clean room environments and processes ensures that the infrastructure meets the necessary quality and safety requirements.

Plant & Machinery Selection

Utilities and other supports