ISO 13485: Certified quality of translations for medical devices

At Skrivanek, we are proud to announce our latest achievement: ISO 13485 certification. This international standard confirms that our translation processes for the medical device industry meet the highest regulatory requirements. But more importantly—it gives our clients confidence that their documentation is handled with precision, safety, and full traceability.

What is ISO 13485 and Why Does It Matter?

ISO 13485 is a globally recognized standard for quality management systems, specifically designed for organizations involved in the lifecycle of medical devices—from manufacturers and distributors to service providers. The certification ensures compliance with strict regulatory frameworks, emphasizing documentation, traceability, and risk management.

For a language service provider like Skrivanek, ISO 13485 means that translations of documentation, instructions for use, clinical trial materials, and regulatory content follow rigorously defined processes. It confirms our commitment to accuracy, consistency, and accountability at every stage of each project.

Who Benefits the Most from ISO 13485?

If you operate in a regulated medical environment, working with an ISO 13485-certified language partner helps ensure that your translations are not only accurate but also audit-ready and aligned with global compliance standards.

Key Benefits for Skrivanek Clients

✔ Regulatory-Ready Translations

Our workflows prioritize terminological precision, structural consistency, and formal correctness—critical factors in approval processes led by notified bodies and regulatory agencies.

✔ Documented and Auditable Processes

Every step, from project intake to delivery, is tracked and quality-assured through certified procedures. Our systems are also aligned with ISO 27001, ensuring high levels of data security.

✔ Specialized Medical Linguists

Your materials are entrusted to professionals with deep domain expertise in medical terminology, clinical phrasing, and industry-specific style guides.

✔ Reduced Language Risk

Our rigorous quality assurance identifies and eliminates ambiguities, terminology errors, and stylistic deviations that could impact product certification or time-to-market.

Why Skrivanek is the Right Language Partner

Choosing the right language provider is a strategic decision—especially in the medical field, where one translation error can delay certification or market entry. Skrivanek offers a unique blend of linguistic excellence and certified quality management:

• ISO 13485, ISO 17100, ISO 9001, and ISO 27001 certifications

• Proven experience with IFUs, clinical trial protocols, UDI labeling, and more

• Dedicated teams trained in regulatory documentation standards

• Terminology management and style consistency across all materials

In the highly regulated medical sector, the quality of your translations reflects directly on your brand’s credibility and compliance status. With Skrivanek, you gain a trusted partner who understands your challenges—and delivers linguistic precision every time.

Let’s talk about your next project.

📩 Contact us to learn how ISO-certified translations can support your global success.