Rosti Group’s Malaysia Molding Site Achieves ISO13485 Certification
The London headquartered plastic injection molding company said the certification of the Malaysian site will allow medical device manufacture there.
Rosti Group announced that its Malaysia injection molding facility has achieved ISO13485 certification, clearing the way for medical device manufacturing at the site. The 5000-m² (approx. 54,000-ft2) facility is Rosti’s fourth plant to attain ISO13485, following China, Romania and Poland.
In addition to injection molding, printing, assembly, process development, tooling and supply chain management, the Malaysia has expertise in the production and validation of complex products. Rosti notes that it was involved in the development and production of a 15-minute COVID-19 saliva test.
Based in Johor, Rosti Malaysia employs 90 staff. Rosti operates eight facilities worldwide, including two Digital Innovation Labs with a third being added in the U.S. Rosti is planning a future investment into a controlled manufacturing area with medical specified injection molding machines.
Located in Johor, Rosti’s Malaysian injection molding facility has achieved ISO13485 certification.
Photo Credit: Rosti Group
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