Creation Technologies is investing in a new ISO Class 7 cleanroom at its manufacturing site in Changzhou, China, to expand its medical device manufacturing capabilities.
The cleanroom is currently in the design phase and is scheduled for completion in March 2027.
It is being designed with Grade C environmental requirements in mind, subject to regulatory and technical assessments, according to the company.
The investment will allow the site to move beyond its existing printed circuit board assembly (PCBA) and box-build manufacturing operations to offer more integrated medical device assembly in a controlled environment.
The Changzhou facility currently manufactures high-reliability PCBAs and complex box-build assemblies for medical and industrial customers.
The additional cleanroom will support the production of precision electronic assemblies, medical equipment subassemblies and other suitable assembly processes requiring environmental control.
Creation Technologies is also developing its digital manufacturing capabilities at the site, including electronic Device History Records (eDHR), to improve production traceability.
The company said the investment is intended to support international medical device manufacturers looking to establish or expand local production in China.
The company has not disclosed the planned cleanroom's size or the value of the investment.
Creation Technologies is a Boston-headquartered electronics manufacturing services provider specialising in the design, engineering and manufacture of high-reliability electronic assemblies for medical technology, aerospace and defence, and industrial customers.
The company works with more than 200 original equipment manufacturers globally, including medical device manufacturers, although it does not publicly name specific clients.