Manufacturing Facilities

The Mi3 clean room facilities are continually monitored to ensure they meet or exceed the requirements of ISO 13485. Particulate counts and Bioburden tests are applied to ensure that the conditions are fully compliant with the manufacture of class I, IIa and IIb sterile medical devices.

At Mi3, we work hard to ensure we meet our customers’ requirements, as well as medical standards. Our medical clean room assembly services ensure a high level of quality control, confidentiality and flexibility to meet our customers’ on-going needs.

The international standard, ISO 14644, regulates all aspects of the setting up, operation and testing of cleanrooms, whilst ISO14698 (parts 1 and 2) covers the control of bio-contamination in relation to clean rooms. Mi3 are audited to these cleanroom related standards via the Medical Device Single Audit Programme (MDSAP), ensuring our strict compliance to all the required regulations for the manufacture of medical devices.

At Mi3, we believe that when choosing a contract manufacturer for your medical device manufacturing and assembly, you should be confident that the cleanroom infrastructure, sterilisation processes and compliance are maintained throughout all levels of manufacturing or assembly.

Mi3’s class 7 facilities are fully equipped for an extensive range of medical device manufacturing processes, including assembly, gluing, automated and manual packaging, pouching, sealing and ultrasonic welding, whilst the dedicated injection moulding and extrusion cleanroom facilities are class 8.

Our dedicated CME facility provides a controlled manufacturing environment for the assembly and manufacture of electrical and other mechanical medical products that do not need to be produced within a cleanroom environment.