LANGUAGE:
LANGUAGE:
Our people are our pride, helping companies resonate with their customers for 20+ years.
We create, transform, test, and train more content than anyone in the world – from text, voice, audio, video, to structured & unstructured data.
Solutions
Our experts know the in-and-outs of your industry & its challenges.
Harness the Lionbridge Lainguage Cloud to support your end-to-end localization and content lifecycle
Our people are our pride, helping companies resonate with their customers for 20+ years.
About Us
Key Facts
Leadership
Insights
News
Trust Center
We create, transform, test, and train more content than anyone in the world – from text, voice, audio, video, to structured & unstructured data.
Content Services
Technical Writing
Training & eLearning
Financial Reports
Multicultural Marketing
Digital Experience Assessments
Translation Services
Translation
Video Localization
Software Localization
Website Localization
Translation for Regulated Companies
Interpretation
Multilingual SEO & Digital Marketing
Content Optimization
Testing Services
Functional QA & Testing
Compatibility Testing
Interoperability Testing
Performance Testing
Accessibility Testing
UX/CX Testing
Solutions
Digital Marketing
Live Events
Machine Translation
Our Knowledge Hubs
Positive Patient Outcomes
Future of Localization
Innovation to Immunity
COVID-19 Resource Center
Disruption Series
Patient Engagement
Lionbridge Insights
Our experts know the in-and-outs of your industry & its challenges.
Life Sciences
Banking & Finance
Retail
E-Commerce
Games
Automotive
Consumer Packaged Goods
Technology
Industrial Manufacturing
Legal Services
Travel & Hospitality
Harness the Lionbridge Lainguage Cloud to support your end-to-end localization and content lifecycle
Lainguage Cloud™ Platform
Connectivity
Translation Community
Workflow Technology
Smairt Content™
Smairt MT™
Smairt Data™
Language Quality
Analytics
SELECT LANGUAGE:
Successful partnerships rely on quality and consistency every step of the way. Our certification for ISO 13485:2016 offers another reason you can count on Lionbridge to deliver just that.
Find out more about our certifications and Life Sciences Services.
ISO 13485—published in 1996, then updated in 2003—provides an international standard for quality management in medical device manufacturing and related services. ISO 13485:2016 was released on March 1, 2016, with a three-year transition period that ends on March 1, 2019.
According to the International Organization for Standardization (ISO), which reviews standards every five years, the 2016 revision is a response to the “latest quality management system practices, including changes in technology and regulatory requirements and expectations.”
The revised standard focuses on risk management and risk-based decision-making for both device manufacturers and external support resources—like Lionbridge Life Sciences.
What this means for partners like you
In the face of increasingly complicated regulatory hurdles, the certification for ISO 13485:2016 reinforces Lionbridge’s commitment to the medical device organizations we work with every day.
As your compliance partner entrusted with translation of critical regulated content, we’ve upgraded our quality management system to reflect the latest requirements and continue to offer high-quality services—all to help our medtech partners reduce risk and improve patient outcomes.
“Our dedication to deliver quality and compliance requires that we continuously match industry standards as a supplier,” says Pia Windelov, Director of Product Strategy for Lionbridge Life Sciences. “Since much of the content we translate is intended for patients, our work contributes to the safe and effective use of medical technologies. We’re always conscious of the potentially life-threatening impact a false diagnosis or misuse of a medical device could have, and we’re committed to ensuring our translations keep patients safe.”
Ready for what’s next
The Lionbridge quality management system has been certified to ISO 13485 standards since 2008, and we recognize the medical device industry’s rising need for accurate, localized translations across a product’s life cycle. Our life sciences translation team is ready to bring linguistic precision to your organization in all markets. Contact us to get started.