Our satisfied clients who use our translation and interpreting services
ISO 13485 Certification
The Highest Standard for Medical Device Translations
Skrivanek is proud to hold the ISO 13485:2016 certification—the international standard for quality management systems specifically designed for the medical device industry.
This certification confirms that we meet the highest requirements for expertise, safety, accuracy, and quality throughout every step of our medical translation process.
ISO 13485: More Than Just a Certificate – It’s Our Commitment
For us, ISO 13485 is not just a formal recognition—it’s a commitment to you, our clients in the medical and pharmaceutical sectors. It means that:
✅ We work with subject-matter experts – Our translators and reviewers have hands-on experience in healthcare and medical devices, and regularly undergo specialized training.
✅ We follow strict quality processes – Every translation is subject to a rigorous quality control workflow, from terminology selection to final proofreading.
✅ We partner only with qualified suppliers – All our linguistic specialists and technical vendors are thoroughly vetted according to clearly defined criteria.
✅ We ensure full regulatory compliance – Our processes meet the requirements of MDR, FDA, and other relevant regulatory frameworks.
✅ We protect sensitive data – All documentation is handled with the utmost confidentiality and data security.
Thanks to ISO 13485 certification, we are fully equipped to be your trusted language services partner in the fields of medical devices, pharmaceuticals, and clinical research.
Whether you need translations of technical documentation, user manuals, regulatory submissions, or marketing materials, you can rely on us for top-level expertise, accuracy, and compliance with current industry standards.