We’re proud to share a major milestone: BIG Language Solutions is now ISO 13485 certified. This certification builds on our existing ISO 17100 certification for translation services. Together, the two standards reinforce an important point for regulated organizations: quality in multilingual content depends not only on sound translation processes, but also on controlled, traceable, risk-aware systems that support how that content is produced and managed.
ISO 13485 is a globally recognized quality management standard associated with the medical device industry. It supports consistent, well-controlled processes, with a strong emphasis on documentation, traceability, risk management, and continuous improvement. For medical device and life sciences organizations working under strict quality and regulatory expectations, that matters.
What is ISO 13485?
ISO 13485 is an international standard for quality management systems (QMS) in the medical device ecosystem. It focuses on establishing and maintaining controlled processes, so work is performed consistently, recorded properly, and improved over time.
Put simply: ISO 13485 helps create a framework for repeatable outcomes and audit-ready documentation, both essential in regulated environments.
What ISO 13485 means for BIG (and for you)
For BIG, certification formalizes the way we operate: with disciplined processes designed to support quality and reliability in regulated environments. Combined with our ISO 17100-certified translation processes, it gives clients added assurance that multilingual content is supported by both strong linguistic quality controls and the traceability, documentation, and risk-based thinking required in medical device and life sciences settings:
1) More consistent delivery
Standardized workflows help reduce variability, especially important when multilingual content supports product use, safety, or regulatory requirements.
2) Stronger traceability and documentation
Clear records and controlled processes support accountability, change control, and audit readiness, useful when demonstrating rigor internally or externally.
3) Risk-aware execution
ISO 13485 reinforces risk-based thinking. This aligns with the reality of regulated content, where translation and localization errors can have outsized impact.
4) Continuous improvement
The framework includes monitoring, corrective action, and ongoing refinement, so quality doesn’t stand still.
Where clients feel the impact most
ISO 13485 strengthens the foundation behind our language workflows across content types such as:
- Instructions for Use (IFUs) and user manuals
- Labels, packaging, and product inserts
- Regulatory and quality documentation
- Software/UI and app content
- Training materials and internal SOPs
- Post-market and customer-facing communications
Why we pursued ISO 13485
Our clients operate under tight timelines and high scrutiny. Achieving ISO 13485 certification reinforces our commitment to supporting regulated organizations with a quality system built for consistency, documentation, and risk-aware delivery. Together with our ISO 17100 certification, it helps clients scale multilingual content, including MT-supported workflows where appropriate, with greater confidence in both translation quality and regulated process control.
What’s next
This milestone is part of our long-term commitment to medical device and life sciences partners. If you’d like to understand how our ISO 13485-certified approach supports your regulated content workflows, reach out to BIG.
