MI3

MI3 LIMITED is a UK-based contract manufacturer specializing in the design, development, and manufacturing of medical and surgical devices, In Vitro Diagnostics (IVDs), and biotech products. They offer end-to-end solutions, guiding innovations from initial ideas to fully validated devices ready for market distribution. Their manufacturing facilities are located in Blackburn, UK.

Their core manufacturing capabilities include thermoplastic engineering, with particular expertise in tubing systems, utilizing processes such as extrusion, injection moulding, and ultrasonic welding. These operations are conducted within a Controlled Manufacturing Environment (CME), with extrusion and injection moulding facilities located within a Class 8 cleanroom. For more sensitive processes, MI3 operates an ISO Class 7 cleanroom, compliant with ISO 14644 and ISO 14698 standards, for the manufacture, assembly, and packaging of Class I, IIa, and IIb sterile medical devices. Additional services include device design and development, prototyping and 3D printing, packaging, and sterilisation.

MI3's regulatory compliance support is a key differentiator, with expertise in navigating post-Brexit regulatory changes, including assistance with Device Files and MDR requirements, CE marking advice, and validation of critical processes. Their Quality Management System is accredited to ISO 13485 via the Medical Device Single Audit Programme (MDSAP). They offer specialist medical device packaging services and expertise in Gamma Irradiation and Ethylene Oxide (EO) sterilisation processes. The company emphasizes vertical integration to speed up decision-making, shorten lead times, and reduce costs.