Steris AMSCO 400 Series

The Steris AMSCO 400 Series is a precision manufacturing system purpose-built for medical device OEMs and contract manufacturers operating under ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.

The AMSCO 400 Series delivers sub-micron repeatability on biocompatible metals, ceramics, and polymers used in orthopaedic implants, surgical instruments, dental prosthetics, and minimally invasive device components. Closed-loop process control with in-process measurement feeds back dimensional data to the controller, correcting for thermal drift and tool wear without operator intervention.

Full process documentation, electronic batch records, and 21 CFR Part 11 compliant audit trails are built into the control software, streamlining validation activities and regulatory submissions for Class II and Class III devices.