Certified, traceable medical device translations
Give your technical documentation the MediLingua treatment.
Give your technical documentation the MediLingua treatment.
Between R&D, clinical trials and regulatory submissions, you know how long it takes to bring a product to market. Don’t let an auditor query a translation and make that wait even longer.
We create certified, traceable audit-ready translations of your technical documentation. Our medical device translations are available in all major languages. We translate labelling, IFUs, patient information, software strings for healthcare apps, and more.
Established companies often have extensive device portfolios with complex documentation that must be respected and consistent. We fit seamlessly into your existing processes.
Startups are often new to the MDR requirements of user or patient information. We guide startups like yours through the tricky phase of producing multi-language versions of your technical documentation.
MediLingua is certified to ISO 9001 and ISO 17100. These certifications are the two stamps of approval that regulatory authorities look for, making our translations perfect for your regulatory submissions. Even so, we don’t believe in just meeting standards. We believe in surpassing them. That’s why we take our quality of translation even further.
At MediLingua, you always get the same project manager and translators. So we are familiar with your needs, and you only have to brief us on your company, product and MDR requirements once.
Working with a single team ensures consistency between products, across languages, and throughout a product’s lifecycle. This enhances the traceability of your multi-language technical documentation.
A question we often get is “How do we do this right?” We’ve been translating technical documentation for medical devices for nearly 30 years. We’re here to guide you on the steps involved and the order to tackle them in.
Technical documentation is hard. At MediLingua, we keep things simple. A single email address and project manager. A select pool of experienced translators. Through direct communication, we build continuity and trust.
Get started with your medical device translation.
You’re about to hand over your technical documentation to strangers. It’s normal to have doubts. Here’s more information to put your mind at ease. If you have other questions, email us.
Some of our clients have established processes and need us to work within tight parameters. Others are starting out in medical devices and need guidance on what to translate, when to translate it and which languages to translate into. Either way, we always translate using our multi-step quality control process. The translation you get back can go straight to market and to your end users. And since it’s certified and traceable, it also meets all your regulatory and auditing requirements.
Yes, they are. We can issue a translation certificate as part of our medical device translation services. The certificate describes the languages of the translation and ISO standard the translation has been carried out to. So the next time an auditor queries the authenticity of a translation, simply submit your translation certificate, let the auditor tick their box, and breathe a huge sigh of relief.
We get versions of this message more often than you’d think. And we’re always happy to issue another certificate. But understand that our translation certificate is more than just a piece of paper to us. It has value. Before we produce one, we match the certificate to the original translation, check the translation and verify the information in the certificate.
This may seem like overkill. But this attention to detail ensures our medical device translation services tick the right boxes with auditors and regulatory authorities.
Actually, no. Here are 3 benefits of investing in a MediLingua translation:
1/ We are a dedicated team of project managers and language specialists. We work on nothing but medical, dental, pharmaceutical and medical technology documents. And we always follow our multi-step quality control process. A premium service like this guarantees smooth sailing through regulatory submission and beyond.
2/ Our rates include translation by an experienced medical translator; revision by a second, equally experienced medical translator; extensive quality checks by our in-house quality assurance team; as well as translation memory management and project management by a dedicated project manager. And we do this for every project and every time. More importantly, there are no hidden costs.
3/ Continuity is one of our strengths. Your projects are handled by a single project manager who understands your needs, is familiar with your products and knows your complete documentation history. The project manager can also arrange to help solve issues with your documentation before translation begins. By getting it right in 1 language, you get it right in all of them.
A MediLingua translation gives you the confidence to market your products in other countries, sure in the knowledge that your documentation is correct.