Rosti Malaysia Achieves ISO13485 For Medical Device Manufacture

Meeting the stringent requirements of the International Organization for Standards for a quality management system will expand on the Group capabilities to deliver medical device prototypes ‘from concept to reality in 72 hours, and extend to full production of medical devices.

The Rosti team overcame obstacles created by COVID to ensure the plant could attain certification in time to support medical device manufacturers. The 5,000 m² facility is the fourth plant of the Rosti Group to attain ISO13485, following China, Romania in 2020 and Poland plant in 2021, and offers a diverse portfolio of capabilities to customers in the medical sectors with agile, total solutions from prototype to manufacture.

The Group was also involved in the development and production of a 15 minute COVID saliva test.

“The team effort in maintaining and continuously improving our systems to attain ISO13485 is a key characteristic of our facility at Rosti Malaysia. This helped us to develop new medical device projects with our customers and bring them to market.

“The way that the team worked together on this certification, considering the roadblocks that COVID-19 created, shows the dedication that the team have in improving Rosti Malaysia for the future,” Rosti IMS Sdn Bhd Managing Director Miller Brown said.

Rosti Malaysia, based in Johor, employs some 90 staff and plays a key role in the China +1 strategy of the Rosti Group.

Having ISO 13485 certified manufacturing facilities and capabilities to manufacture products and components for medical device, diagnostic (IVD) and pharmaceutical markets, provides the opportunity to develop extensive working relationships with current customers and opens opportunities to grow within the life sciences sector. Rosti Malaysia has already attained ISO9001, ISO14001, ISO45001 and is UL Certified.