HONG KONG, Oct. 7, 2025 – Clearly Local, a leading provider of global content solutions, is proud to announce its achievement of the ISO 13485:2016 certification, a globally recognized standard for quality management systems in the medical device industry. This milestone marks a significant step forward in Clearly Local’s commitment to delivering precise, compliant, and high-quality translations for life sciences organizations worldwide.
Enhanced Capabilities for Life Sciences Clients
The ISO 13485 certification reinforces Clearly Local’s operational framework with a systematic approach to risk management and regulatory readiness. This enhances the company’s services for the medical sector in several key areas:
- Regulatory Compliance: The quality management system is explicitly aligned with international regulatory requirements, ensuring translations support submissions to the FDA, EMA, and other global agencies.
- Comprehensive Quality Assurance: Beyond linguistic accuracy, the certification enforces stringent controls for document traceability, version control, and validation protocols, which are critical for technical documentation and labeling.
- Proactive Risk Management: Potential errors are systematically identified and mitigated throughout the project lifecycle, reducing the risk of costly delays or non-compliance issues for medical devices entering new markets.
“This certification provides our life sciences clients with an added layer of confidence,” said Jill Huang, Customer Success Director at Clearly Local. “It is our formal guarantee that their critical medical device translations will meet the most rigorous global quality and regulatory standards, simplifying their path to market.”
Looking Ahead
Clearly Local plans to expand its life sciences offerings to include deeper support for clinical trials, regulatory submissions, and patient-facing content. The company is also investing in advanced technology solutions to streamline compliance and improve turnaround times.
As part of this strategic focus, Clearly Local is now pursuing the ISO 18587:2017 certification for full, human post-editing of machine translation output. This upcoming certification will provide a validated framework for efficiently managing high-volume content while guaranteeing the final quality meets regulated industry standards.
About Clearly Local
Clearly Local was launched by veterans of the localization industry with a fresh approach to content creation and translation solutions. At Clearly Local, we adhere to the three principles of Transparency, Efficiency, and Quality. Our people-focused hybrid working model makes the most of talent from around the world for maximum cost effectiveness. We choose people who find true satisfaction from work. When you work with us, you’ll discover that every single person on the Clearly Local team is personally motivated to Translate Your Value to the World. Learn more at: https://www.clearlyloc.com/
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Media Contact: pr@clearlyloc.com
