Supporting IOPI Medical’s Global Expansion
IOPI Medical is a medical device company focused on delivering clinically validated solutions in a highly
regulated environment where accuracy, compliance, and clarity are essential, particularly in medical
device labeling and Instructions for Use (IFUs).
As the company expanded internationally, IOPI Medical required reliable, regulation-compliant
translations across multiple European languages to support product launches in new markets.
Language Scientific has served as a trusted translation partner, supporting a wide range of medical
device documentation, including IFUs and other standard regulatory materials.
Language Scientific works directly with Tara Mythen, PhD, President & CEO of IOPI Medical, providing
expert medical translations supported by clear communication and a streamlined project management
process
The Problem
IOPI Medical needed medical device documentation translated into multiple European languages to
support international product launches. Because these materials are patient- and regulator-facing,
accuracy and compliance were absolutely critical.
The challenges included:
- Meeting strict regulatory requirements for medical device labeling
- Translating content into multiple European languages, including Greek, Dutch, French, and German
- Ensuring accuracy, consistency, and correct formatting across all deliverables
IOPI Medical required a translation partner with proven medical device expertise and strong quality
assurance processes to support global expansion without delays or rework.
ACTIONS TAKEN
- Delivered expert translations for medical device documentation, including IFUs, across multiple European languages
- Applied medical and regulatory expertise to ensure accuracy and compliance
- Implemented rigorous quality assurance to eliminate errors and formatting issues
- Maintained a smooth, well-managed workflow aligned with internal processes
- Ensured clear, consistent communication throughout each project
