Rosti Malaysia Achieves ISO13485 Certification for Medical Device Manufacturing

Rosti Group is delighted to have achieved ISO13485 certification at our Malaysia production facility.

Meeting the stringent requirements of the International Organization for Standardization for a quality management system will enhance the Group’s capabilities to deliver medical device prototypes from concept to reality in 72 hours, and also allows for full production of medical devices.

The Rosti team overcame challenges created by COVID to ensure the plant could achieve certification in time to support medical device manufacturers. The 5,000 m² facility is the fourth Rosti Group plant to achieve ISO13485, following facilities in China, Romania (2020), and Poland (2021), and offers a wide range of capabilities to customers in the medical sector, providing agile, comprehensive solutions from prototype to manufacturing.

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

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

“The way the team worked together for this certification, despite the obstacles that COVID-19 created, shows the dedication everyone has for improving Rosti Malaysia for the future,” said Rosti IMS Sdn Bhd Managing Director Miller Brown.

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

Having ISO 13485 certified manufacturing facilities and capabilities to produce products and components for the 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 achieved ISO9001, ISO14001, ISO45001 and is UL Certified.