Ciklopea d.o.o.

We are a specialized localization and translation company supporting Life Sciences and medical device organizations in global markets.

With ISO 13485-certified processes, we deliver multilingual documentation aligned with medical device quality and regulatory requirements, with a strong focus on confidentiality, accuracy, and full traceability.

Our expertise goes beyond translation. We support EU MDR, IVDR, FDA and CE documentation, including clinical documentation, IFUs, labels and packaging, technical documentation, and software localization.

Through medical expertise, consistent terminology, controlled linguistic validation, and audit-ready workflows, we help our clients reduce regulatory risk and bring their products to global markets with confidence.