The goal of this step is to prepare the developed product for large-scale industrial production, allowing product commercialization. The deliverable of this step is a fully operational production line.
• Design, develop, setup and validate the production line of the device;
• Design, prototype and validate labels, instructions and packaging;
• Develop and validate operational and assembly procedures;
• Prepare and submit documentation to regulators;
• Planning and deployment of standard operating procedures training;
• Planning and deployment of good manufacturing practices procedures training;
• Run a pilot product batch;
• Submit to certification.