BIG Language Solutions Achieves ISO 13485 Certification - What This Means for Medical Device & Life Sciences Teams

BIG strengthens support for medical device and life sciences clients with certified, traceable language workflows for regulated content.

This certification reinforces our ability to support clients with processes that are designed for linguistic excellence and the strict quality and audit requirements of the medical device industry.”

— Anna Valsamaki, SVP of Translation Operations

GA, UNITED STATES, March 17, 2026 /EINPresswire.com/ -- BIG Language Solutions (BIG), a technology-driven language solutions partner supporting regulated industries, has achieved ISO 13485 certification for its quality management system, an internationally recognized standard focused on consistent quality and risk management for organizations supporting the medical device sector. This builds on BIG’s ISO 17100-certified translation processes, strengthening its ability to support life sciences organizations with language workflows that combine translation quality with the control and traceability needed in regulated environments.

ISO 13485 is designed to help ensure organizations have robust, documented processes for quality, traceability, and continuous improvement, principles that are central to regulated healthcare and life sciences environments. Combined with BIG’s ISO 17100-certified translation processes, the certification reinforces BIG’s commitment to operational discipline and repeatable quality across translation, localization, language validation, and MT-supported workflows used in life sciences content. For customers, that means language services can be scaled with greater confidence that both linguistic quality and regulated process requirements are being addressed.

With ISO 13485 certification, BIG’s clients can expect:

• A quality system aligned with medical device expectations: Documented, controlled processes designed for regulated environments where accuracy and consistency matter.

• Confidence in translation quality and regulated delivery: With ISO 17100 guiding translation processes and ISO 13485 strengthening quality management in regulated environments, clients can feel confident their content is supported by workflows built for accuracy and control.

• Stronger process controls and traceability: Clear workflow documentation and records that support audits, change control, and accountability.

• Risk-based thinking built into delivery: Structured approaches to identifying, mitigating, and monitoring risks that could impact quality.

• Continuous improvement: A formal framework for measuring performance, addressing nonconformities, and improving over time.

• Confidence when scaling global content: A quality foundation that supports multilingual documentation across products, markets, and timelines.

BIG supports customers with multilingual content across product and regulatory documentation, labeling and packaging, instructions for use (IFUs), software/UI strings, clinical and post-market materials, training content, and customer-facing communications, helping ensure clarity, consistency, and readiness for global markets.

About BIG Language Solutions:

BIG Language Solutions helps complex organizations trust every word of their interpretation and translation services. Clients rely on BIG for expert support delivered exactly when and how they need it.

Vicky Teixeira
BIG Language Solutions
info@biglanguage.com
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