In response to a customer’s requirements, Rosti Poland was recently awarded ISO 13485.
Responding quickly to customer needs, Rosti Poland has successfully achieved ISO 13485 certification, which is a key part of our growth strategy as a leading contract manufacturing partner in the Life Science and Medical sectors.
In partnership with a Life Science customer, the Rosti team has worked tirelessly to implement the necessary processes and procedures to gain this recognized accreditation, demonstrating our commitment to both current and potential life science customers.
Our customer was looking for a reliable plastic injection molding company with controlled environment capabilities and the capacity to meet their production needs.
By adapting our procedures and infrastructure to support robust and validated precision manufacturing processes in a certified, controlled environment, we were able to fulfill their production requirements.
Achieving ISO 13485 certification represents a significant investment from Rosti, which includes a controlled manufacturing area with medically specified injection molding machines that allow us to operate 27 molds, as well as the use of materials requiring antistatic and antibacterial compliant additives with full traceability.
Having certified manufacturing facilities and the capability to produce products and components for the medical device, diagnostic (IVD), and pharmaceutical markets creates opportunities to build strong working relationships with current customers and opens the door to growth within the life sciences sector.
