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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.