Reacting quickly to a customers needs; Rosti Malaysia are targeting to be awarded ISO 13485 in November 2021 which is a fundamental part of our growth strategy as a leading contract manufacturing partner in the Life Science and Medical sectors.
In collaboration with a Life Science customer, the Rosti team have worked tirelessly to implement the appropriate processes and procedures to achieve the recognised accreditation, demonstrating our commitment to current and potential life science customers.
Adapting our procedures and infrastructure allows robust and validated precision manufacturing processes to be carried out in a certified environment will enable us to fulfil their production requirements.
Achieving ISO 13485 accreditation represents a significant investment from Rosti Malaysia, including a future investment into a controlled manufacturing area with medical specified injection moulding machines allowing us to operate at a medical level with full traceability.
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.