Manufacture & Assembly

Our medical equipment manufacturing cleanroom facilities offer a mix of ISO Class 7 and Class 8 production and assembly areas.  We also have a controlled manufacturing environment, (CME), available for manufacturing and assembly processes that do not require the stringent environments of a Class 7 cleanroom.

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 with regulatory standards are maintained throughout all levels of manufacturing or assembly that you require.

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 medical device manufacturing processes are validated to provide maximum possible assurance of repeatable quality, and we continuously strive to improve these processes with regular training programmes. The manufacture of your medical devices and medical products could not be in safer hands.

‍The clean room requirements for medical device manufacture are stringent to ensure regulatory compliance for our customers, the medical device companies.

Mi3’s clean room manufacturing and assembly services take place within clean rooms compliant to the principal regulations governing the operation of cleanrooms with respect to the assembly of medical devices, namely ISO 14644.

The international standard, ISO 14644 regulates all aspects of the setting up, operation and testing of cleanrooms. Mi3 we are fully compliant to these cleanroom related standards and audited to ISO 13485:2016 via the Medical Device Single Audit Programme (MDSAP) ensuring our strict compliance to all the required regulations for the manufacture of medical devices.

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.

The range of services offered within the scope of our manufacturing services include:

• Manual & Automated Clean Room Assembly
• High Tolerance Injection Moulding
• Extrusion
• Thermoplastic Ultrasonic Welding & Assembly
• Manual & Automated Product Packaging
• Terminal Packaging Solutions - including automated form fill seal equipment
• Sterilisation