Global Content Solutions for Medical Devices
TransPerfect Medical Device Solutions is the first supplier to combine ISO 13485, 14971, and 9001 certified, patented language services with validated process automation technologies to meet the content management challenges of evolving regulations.
Our ISO 13485, 14971, 9001, and 17100 certified quality system, which is specifically designed for medical device translations, ensures compliance with MDR, IVDR, and other regulatory requirements.
Properly mitigate the hazards of translating labeling content including IFUs, websites, software, and more with our tested, specialized linguistic resources along with the only medical device-specific quality system in the industry and our patented risk management solution.
AI technologies are playing an increasing role in meeting the content requirements of MDR and IVDR for post-market vigilance and labeling production. TransPerfect MDS is ISO-certified for implementation of AI processes and has helped manufacturers like Medtronic achieve 80% cost savings in critical PMS and labeling applications.
Marketing & Digital Support
We offer advanced localization services, specialized linguistic resources, and a suite of technology tools to support compliance with new MDR and IVDR requirements—as well as a range of production strategies to help address specific market needs.
Our localized e-learning content can train your teams on evolving regulations and meeting compliance requirements.
Clinical Trials & Clinical Affairs
Our eClinical technology, Trial Interactive, offers an author-to-archive platform and TMF services to ensure inspection readiness and quality with streamlined and automated eClinical solutions for required GCP compliance across the clinical lifecycle.
Patent & Litigation Support
Our patent and litigation support saves manufacturers significant costs and time with direct billing for critical support services.
Post-Market Surveillance (PMS)
Our translation services and automation technologies help you address the vastly increased content requirements of MDR and IVDR.