The safest route to certified, traceable medical device translations
Manufacturers and startups, market your medical device across languages with our ISO-certified medical device translation services.
Don’t get stuck in auditing
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. Be audit-ready with our medical device translation services.
Get approved translations for your medical device
We create certified, traceable audit-ready translations of your technical documentation. Our medical device translations are available in all major languages, and cover labelling, IFUs, patient information, software strings for healthcare apps, and more.
Submitting your translation to regulatory authorities?
MediLingua is certified to ISO 9001 and ISO 17100, so we can give you a translation certificate to prove the authenticity of your translation and speed up the approval of your submissions.
We work with medical device manufacturers like you
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.
Why trust our medical device translation services?
Continuity
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.
Consistency
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.
Guidance
A question we often get is “How do we do this right?” With 30 years of translating technical documentation for medical devices, we can guide you on the steps involved and the order to tackle them in.
Human size
Technical documentation is hard. At MediLingua, we keep things simple. A single email address, a single project manager and a select pool of regular translators to build continuity and trust.
Get accurate, consistent translations for CE marking and market launch.
FAQs
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.
How do your medical device translation services work?
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 ISO-certified and traceable, it also meets all your regulatory and auditing requirements.
Are your translations accepted by auditors and regulatory authorities?
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. If 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.
Please send me a copy of your translation certificate. We’re being audited today!
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.
Are your rates high?
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 multiple languages, sure in the knowledge that the translations of your documentation are accurate, consistent and respected.