Ciklopea Achieves ISO 13485 Certification
Ciklopea Consulting */ ?> We are proud to announce that Ciklopea has just received a globally recognized quality standard for the medical device industry – ISO 13485 certification.
At the same time, we have recently earned ISO 27001:2022, an upgrade from ISO 27001:2013, expanding our Information Security Management System to include software development.
We have also passed expert audits for ISO 9001, ISO 17100, and ISO 18587, thereby proving the continued advancement of our 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 transition to ISO 27001:2022 encompasses the necessary software development standards and covers security requirements for both service delivery and technology development. It also includes Orchestrum TBMS, Ciklopea’s translation business management system, which ensures secure data management throughout the 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.
With the newly earned certifications, we will continue to help organisations of all sizes meet their multilingual communication goals and compliance requirements on a global scale.