Executive Brief: Anatomy of a Multilingual IFU

If you are planning a multilingual IFU, you will need to scope out printing, packaging, and translation services. By working through this process in the right order, you can save yourself time, reduce your overall project spend, and sidestep major headaches.

But which order is the most optimized?

Navigate your way around project inefficiencies: read the brief!

Here we come, Philadelphia!

Only three weeks until #2019RAPS! If you will be in Philadelphia, stop by to talk translations with us at booth #626. We would love to help you streamline translation spend, reduce regulatory headaches, and bring your global strategy into focus.

See you there!

We’re heading to Chicago…

…to attend the 9th Annual Medical Device and Diagnostic Labeling Conference, May 14-15. We’re excited that our very own Nancy Kellen will be moderating a special panel on how to partner with a translation provider for long-term success. Having served the life sciences community for 35 years, we know a little something about crafting enduring relationships!

If you’d like to get in touch before the conference, we’d love to hear from you.

See you in Chi-Town!

Executive Brief: Translation and ISO 13485

Working through an upgrade to ISO 13485:2016? Make sure that translations don’t fall through the gap analysis!

Risk evaluation, quality agreements, and verification of product are all vital components to the new standard. But what do these mean for your translation process?

We have put together some points to ponder. Check them out!

Idem Upgrades Quality Management System to ISO 13485:2016

We’re pleased to announce our upgraded certification to the 2016 revision of ISO 13485. Our quality management system is a vital part of our commitment not only to our medical device customers, but also to the patients, physicians, and regulators around the globe who read our translations. In addition to ISO 13485:2016, our quality management system is certified to ISO 9001:2015 and ISO 17100:2015.

ISO 13485, the international standard for quality management system requirements for medical devices, helps organizations to establish reliable processes that reduce the risk of defect or error. Key elements of the 2016 revision revolve around improved supplier controls and deeper process validations.

Read our full press release here.

Executive Brief: How to Evaluate Translation Suppliers

Shopping for a translation partner? How can you tell which one is the right fit for your team?

You need to understand how translation providers differentiate themselves in a competitive marketplace and how those differentiators might benefit your organization. Like Goldilocks, you need to assess potential providers to find the one that is “just right.”

Learn how to evaluate potential suppliers against the three F’s: focus, function, and fit…
Download the brief!

Looking Forward to the RAPS Convergence 2018!

Idem is delighted to announce that we will be attending the 2018 RAPS Convergence in beautiful Vancouver, British Columbia. Stop by and see us to talk translations, MDR requirements, and risk mitigation in multilingual strategies.

If you already have pressing questions, drop us a line.

See you in B.C.!