Rosti Malaysia awarded project to produce 15-minute COVID-19 test for a global molecular diagnostics company

After achieving ISO13485 accreditation, Rosti Malaysia has partnered with a global molecular diagnostics company to manufacture a COVID-19 test that delivers results in just 15 minutes.

The product’s development followed a risk management approach to ensure compliance with regulations and certifications required by the US FDA. The entire manufacturing process, including tool trials and the development of assembly processes, was completed according to medical process qualification standards incorporating the IQ/OQ/PQ procedures, and has received approval to begin mass production.

Strict environmental and process controls are necessary during the production of parts for the COVID-19 Test, and the Rosti Malaysia team is confident in meeting these requirements thanks to the knowledge and training gained during ISO certification.

This marks a key milestone for Rosti Malaysia in starting to attract new customers in the life sciences industry. This also aligns with Rosti Group’s business development strategy for the medical market.

Founded in 1944, Rosti is a global leader in technical plastic injection molding, serving various markets. We have medical production facilities in Poland, Romania, China, Malaysia, and the US, all with ISO13485 accreditation.

In recent years, Rosti has expanded our services by getting involved earlier in the product development phase, supporting our medical clients with product design, development, functional testing, and mass production. Backed by our Innovation Center and 3D printing technology, your design can become a reality in just 72 hours!