ISO 13485:2016

Guaranteeing Top Standards in Medical Translations

The ISO 13485 standard defines the requirements for a quality management system (QMS) specific to companies involved in the medical device industry. Its main goal is to ensure consistency, safety, and quality in products and services throughout all stages – from design and production to distribution and post-market support.

At Skrivanek, we understand the critical importance of precision and regulatory compliance in the medical field. That’s why we have implemented and maintain a quality management system that complies with ISO 13485. This certification confirms our capability to deliver language services and translations that meet the highest standards required by the medical and life sciences sectors.

What does ISO 13485 mean for our clients?

Obtaining ISO 13485 certification is more than a formal step – it is a reflection of our commitment to excellence. For our clients, this means:

• Medical and technical translations are carried out with the utmost accuracy and in compliance with all relevant regulations and guidelines.
• We ensure full traceability of processes and rigorous quality control at every stage of a project.
• Our procedures are regularly audited and continuously improved, minimizing the risk of errors and ensuring information security.