ISO 13485:2016 Certification Enhances Quality Management in Medtech

Posted January 17, 2019 by Matt Fishbein

The new standard translates into more consistency, less risk, and continued quality for Lionbridge partners

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.

March (first) to the new standard

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.

Key requirements for medtech manufacturers under ISO 13485:2016 certification include:

• Maintenance of a comprehensive technical file for each manufactured device
• Validation of contamination control processes for sterile medical devices
• Monitoring and measurement for complaint handling and regulatory reporting
• A clear definition of specific skills and experience of quality management personnel, plus verification of ongoing training effectiveness
• Formal processes for obtaining and incorporating production and post-production feedback into risk management programs
• Deep validation of quality management system software

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.