Swedish injection moulder Rosti’s (Malmo; www.rosti.com) recently completed 10,000 m² manufacturing facility in Romania has started producing amniotomy devices for an unnamed new life sciences customer, the injection moulder announced.

Details of the contract were not disclosed, but in a statement Rosti said that the client had faced challenges around the quality of its design drawings. Rosti added that it was able to make reverse-engineered 3D scans and review existing 2D drawings to identify improvements. The Swedish company then created 3D files and 2D drawings of the medical device, which were sent to the customer for approval before work on the project began.

The unnamed life sciences customer will have a dedicated production area at the Romanian plant to manufacture the amniotomy medical device, which meets the customer’s specification in combination with ISO 13485 accreditation. Rosti established a manufacturing presence in Romania in 2013. The new 10,000 m² plant can be expanded by a further 8,000 m², the company said.