Source: MadCap Software, Inc.

MadCap Software Achieves Coveted ISO 13485 Certification for its MadTranslations Group to Extend Support for Translating Medical Device Companies’ Documentation

Certification in the ISO 13485 medical device quality management system standard complements MadTranslations’ existing certifications in ISO 17100 for translation quality and ISO 9001 for quality management

San Diego, CA, June 01, 2020 (GLOBE NEWSWIRE) -- MadTranslations, the industry-leading translation and localization services arm of MadCap Software, Inc., today announced that it has achieved International Standards Organization (ISO) 13485:2016 certification. ISO 13485:2016 is the latest version of the globally recognized quality management system (QMS) standard for the design and manufacture of medical devices—covering everything from test kits and scalpels to MRI machines and ventilators. With this certification, MadTranslations significantly simplifies the ability of medical device customers to confirm that their translations meet rigorous ISO 13485:2016 requirements and quality standards.

Increasingly, medical device companies and other enterprises worldwide rely on MadTranslations for best-in-class services around language translation; localization of software, websites, multimedia, technical documentation, and e-learning content; and terminology management. These services are delivered by the organizations’ global team of highly technical translators and project managers with decades of experience working with government agencies and large multinational companies. Year-to-date alone, MadTranslations has seen revenues from its translation and localization services increase more than 60% compared to the same period last year. 

The new ISO 13485:2016 certification extends MadTranslations’ long-standing commitment to supporting the quality standards that drive the best practices of organizations around the globe. The business already has been certified for two other widely adopted ISO standards since 2016. ISO 9001:2015 is the most current ISO standard governing QMS processes designed to help companies focus on customer requirements. Meanwhile, ISO 17100:2015 is the latest ISO standard for translation services, which establishes quality criteria for translators and revisers, covering both competency and processes for project management.

“As a manufacturer of medical devices sold all over the world, CIVCO Medical Solutions provides labeling and instructions in 31 different foreign languages,” said Julie Miller, technical communications lead for CIVCO Medical Solutions. “MadTranslations has been providing us with quality translations that meet our strict regulatory requirements since 2016. The people and systems they have in place, along with the integration with MadCap Flare, have reduced our time to market significantly. We produce instructions for medical devices with confidence, knowing our translations are the very best they can be.”

“Many of our customers deliver products that need to meet the strictest quality standards, and nowhere is that truer than in the medical device industry,” said Mike McDermott, language services director for MadTranslations at MadCap Software. “From the start, we have put a priority on helping customers apply quality management best practices across their localized content and code, by making early investments in the ISO 9001:2015 and ISO 17100:2015 certifications. Now, as an ISO 13485:2016-certified provider, we’re excited to extend this commitment and strengthen our translation and localization support for medical device companies worldwide.”

About MadTranslations
As a leading provider of technical translation and localization services, companies around the globe rely on MadTranslations for translated and localized content that is functionally, linguistically, and culturally flawless. Our quality management process ensures we deliver technically accurate translations and localization solutions to help companies succeed in international markets. Our unique understanding of the technical authoring industry, combined with the highest commitment to customer satisfaction and value, ensures every stage of the project lifecycle meets the highest quality standards. Our tools leverage previously translated text to reduce the time and cost of translating new projects and rely on stored terminology to ensure consistency across every client project. For more information, visit

About MadCap Software        
MadCap Software, Inc. is a trusted resource for thousands of companies around the globe that rely on its solutions for single-source multi-channel authoring and publishing, multimedia, and translation management. Whether delivering technical, policy, medical, marketing, business, or human resources content, MadCap’s products are used to create corporate intranets, Help systems, policy and procedure manuals, video tutorials, knowledge bases, eBooks, user guides, and more to any format, including high-end print, online, desktop or mobile. MadCap services include product training, consulting services, translation and localization, and an advanced developer certification program. Headquartered in San Diego, California, MadCap Software is home to some of the most experienced software architects and product experts in the content development industry. Learn more about MadCap Software at

MadCap Software, the MadCap Software logo, MadTranslations, the MadTranslations, logo, MadCap Central, and MadCap Flare, are trademarks or registered trademarks of MadCap Software, Inc. in the United States and/or other countries. Other marks are the properties of their respective owners.

Rebecca Hurst
Kinetic.PR for MadCap Software