In response to a customer’s requirements, Rosti Poland have recently been awarded ISO 13485

Rosti • Case Studies • In response to a customer’s requirements, Rosti Poland have recently been awarded ISO 13485

Reacting quickly to a customers need; Rosti Poland have successfully been awarded ISO 13485 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.

Our customer was in search of a reliable plastic injection molding company who has controlled environment capabilities and capacity to fulfil their production requirements.

Adapting our procedures and infrastructure to allow robust and validated precision manufacturing processes to be carried out in a certified and controlled environment enabled us to fulfil their production requirements.

Achieving ISO 13485 accreditation represents a significant investment from Rosti, including a controlled manufacturing area with medical specified injection molding machines allowing us to operate 27 moulds and the use of materials that require antistatic and antibacterial conformed additives with full traceability.

Having 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.