Our medical equipment manufacturing cleanroom facilities offer a mix of ISO Class 7 and Class 8 production and assembly areas.

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.

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.

Meeting Medical Standards

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.

“Mi3 has a customer focus culture and it is dedicated to helping solve issues and improve output quality. Medela AG has seen how Mi3 is passionate about assisting us to scale up the business”. 
Daniele Samuel Pascovici, Project Sourcing Healthcare, Medela AG

Understanding Your Requirements

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.

Regulated Cleanrooms

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.

Facilities to Meet Your Needs

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.

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