Ciklopea, a distinguished European provider of translation and localization services, has announced they have successfully achieved ISO 13485 certification – a globally recognized quality standard for the medical device industry.
The certification comes as Ciklopea has recently earned ISO 27001:2022, an upgrade from ISO 27001:2013 expanding its Information Security Management System to include software development. The company has also passed expert audits for ISO 9001, ISO 17100, and ISO 18587, having proved the continued advancement of its integrated management systems.
These recent certifications confirm that Ciklopea is a trusted language solutions partner for highly regulated industries such as life sciences, technology, and manufacturing.
Strengthening compliance, risk management, and trust
Obtaining ISO 13485 certification demonstrates Ciklopea’s readiness to support medical device manufacturers and pharmaceutical companies. Language is an important subject in regulatory documents, clinical processes, and patient information and guidance. Apart from that, quality, traceability, and risk management are vital features for full compliance and utmost security in these areas.
The shift to ISO 27001:2022, which encompasses the necessary software development standards, as well covers security requirements for both service delivery and technology development. It also includes Orchestrum TBMS, Ciklopea’s translation business management system that ensures secure data management in the entire content lifecycle.
Together with ISO 9001, ISO 17100, and ISO 18587, these standards build an integrated framework that delivers superior quality, robust data protection, clear process transparency, and continuous improvement.
Long-term commitment to operational excellence
Ciklopea has been at the forefront of premium translation, localization, and language technology solutions for more than 20 years. The successful implementation and maintenance of the five ISO standards above is a token of long-term commitment to strong practices and international compliance.
The result of these procedures is the integration of quality control, information security, linguistic standards, and legal provisions into a single operational system. Ciklopea has always delivered scalable, audit-ready language solutions to clients operating in complex regulatory environments. The recent ISO certifications represent the official confirmation of Ciklopea’s professional excellence.
About Ciklopea
Ciklopea, established in 2003, is a Southern Europe–based language solutions provider specializing in high‑quality translation and localization for regulated industries. With ISO‑certified processes, advanced technology, and expert in‑country linguists, Ciklopea delivers tailored multilingual solutions across life sciences, technology, manufacturing, corporate communications, and more — helping global companies expand, comply, and communicate with clarity.
