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!
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.
I have my English content drafted. Now I need to translate it into a bunch of languages. How do I get it formatted and into the box for shipping?
Get some fast facts here!
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!
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.!
Do you manage all your labeling in Microsoft Word? Are you adding multiple, international markets and wondering if your IFU can keep up?
You can reduce risk and plan for success! But you need to know when to transition your documentation to a formal desktop publishing application. This brief talks about what Microsoft Word does well and when it might no longer be the right application for your content.
If you’re already planning a transition, we also spell out the key things you want to consider to ensure that your new document format meets your team’s needs.
Get your team ready for growth. Download the brief!
Planning to translate your software or mobile app? You can ensure a pain-free project with a bit of advance planning!
This brief gives you insight into the key elements of a string-based translation project, from the big picture strategy to the tiny details that can impact user understanding in translation.
Here’s what you need to know before you begin. Download the brief!
The world is aflutter with the power of machines. Robots are delivering your lunch order in cities around the US. Neural networks are driving major changes to automated translations. For decades, people have been predicting that humans will become unnecessary to the translation process.
Machines are great, but we believe in people.
We believe that our clients receive the best quality from people who love their jobs. We believe that our clients receive the best value when their translations are right the first time. We believe that our clients receive the best service from a team that never makes the same mistake twice.
So, today, we want to express our appreciation for the fantastic humans who make translations happen with trained neurons and hard work. These are devoted project managers, masterful linguists, savvy desktop publishers, and eagle-eyed quality control experts.
Thank you for all the irreplaceable things you do!
Should you have one vendor to maximize cost savings? Or multiple vendors to reduce the risk of single sourcing?
Our brief will help you design the translation vendor strategy that’s right for your team by explaining key concepts in translation vendor management.
Get the most from your translators: Download the brief!
We’re pleased to announce our upgraded certification to the 2015 revision of ISO 9001. Our quality management system is a vital part of our commitment to meet our clients’ needs and exceed their highest expectations. In addition to ISO 9001:2015, our quality management system is certified to ISO 13485 and ISO 17100.
ISO 9001, the international standard for quality management system requirements, helps organizations function more efficiently and improve customer satisfaction by establishing reliable processes and improving them year over year. An emphasis on risk-based thinking and clearer language for service organizations are key elements of the 2015 revision.
Read our full press release here.