Create synergy across product documentation

Bridge the gap

Distributors are essential partners in bringing medical devices to the patients who need them. As EU MDR Article 16 adds new responsibilities to your work, Idem is here to help.

We work directly with manufacturers to translate content from the full device life cycle, including legal and marketing materials. Headquartered in the United States and working with EU-based production resources, we assist distributors to translate labeling consistently with all other device documentation to ensure a seamless international voice for each product.

Ensure accuracy

You need accurate, up-to-date translations of instructions for use and product labels to distribute devices across a global marketplace.

A triple-certified quality management system gives you peace of mind that medical translators are properly vetted and qualified to translate technical documentation. We work with in-country linguists who have proven expertise in the life sciences. And we monitor their work regularly so you always get the highest quality translations.

Create synergy

As you take on new regulatory responsibilities, you exercise greater control over resource selection. So you can choose the right translation partner to support your long-term needs.

We collaborate with in-country stakeholders to review translated materials and make certain that translations always use the preferred, local terminology for each device. Together with our distributor and manufacturer clientele, we make life-changing devices accessible to patients worldwide.