Mi3's Controlled Manufacturing Environment (CME) is a dedicated space for manufacturing and assembly of IVDs and medical devices that do not require stringent cleanroom protocols.

Within this area we have the ability to produce complex mechanical assemblies, which can often feature a large number of parts. In order to produce these types of assemblies demands a high level of skill, precision, accuracy and consistency.

The awareness of critical engineering tolerances and the use of mechanical tools and gauges for use in both pre checks and in process testing is key when producing mechanical assemblies of this complexity.

Electronics, orthopaedic and wound management products are just a few examples of the type of medical device sectors that can benefit from utilising this space for their product manufacture and assembly. 

Electromechanical Products

Complex equipment including medical devices with electrical components can be assembled in our dedicated Controlled Manufacturing Environment.

Our CME space is versitle and our development and manufacturing teams can validate and implement a range of manufacturing processes to suit your specific requirements and anticipated volumes.

Within this area we have:

  • Dedicated benches with ESD controls in place
  • Ability to deal with complex cabling and electrical assemblies
  • Capabilities to upload firmware and perform functional end of line tests on products.

 

We can complete configure to order (CTO) products with outbound logistics (direct ship fulfillment).

Mechanical Product Assembly

Mi3 provide mechanical product and component assembly solutions for devices that, for example, do not require stringent cleanroom conditions or to be supplied sterile, namely Class I, non-invasive medical devices.

Our CME space is versitle and our development and manufacturing teams can validate and implement a range of manufacturing processes to suit your requirements and anticipated volumes. 

 

We can complete configure to order (CTO) products with outbound logistics (direct ship fulfillment).

Mi3 News

Regulatory Update - IVDR Implementation Amendment

EU Commission’s proposed amendment to transition period of the In Vitro Diagnostic Devices Regulation (IVDR) calls for a progressive roll out.

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Mi3 News

Student Placement Blog

In July 2021, Mi3 took on four students from different universities to participate in “A Year in Industry”. Over the course of the year, the students will post multiple blog entries here, to showcase their experiences, highlighting some of the key activities they are involved in.

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Mi3 News

Amendment of MDR (EU) 2017/745|OJ L241/7 on 8th July 2021

On 8 July 2021 an amendment to the Regulation on Medical Devices MDR (EU) 2017/745 was published in the Official Journal of the European Union with some changes and corrections, including, misprints, typos and translation errors.

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Testimonials

Speak to our experts about our CME Facilites