Following the ISO13485 accreditation, Rosti Malaysia has partnered with a Global Molecular Diagnostics company to manufacture a COVID-19 test within 15 minutes.
The development of the product used risk management approach to ensure that the products comply to the regulation and certification required by the US FDA. The whole manufacturing process including tool trials and assembling process development has been completed according to the medical process qualification requirements incorporating the IQ/OQ/PQ process and has got the approval to start mass production.
Stringent environment and process control is required during the production of the parts for the COVID-19 Test and Rosti Malaysia’s team is confident of achieving them with the knowledge and training gained during the ISO certification.
Rosti, founded in 1944, is a technical lead global plastic injection moulding company in various markets. We have medical production facilities in Poland, Romania, China, Malaysia and US, with ISO13485 accreditation.
Recent years, Rosti expanded our services by moving up-stream in the product development phase, helping our medical customers leading the product design, development, function test and mass production, with the support of our Innovation Center 3D printing technology, from where your design can be realised in 72 hours!