It’s simple, really. Without medical device translation services, there can be no global medical device industry. Patients, healthcare professionals, and regulatory authorities speak different languages. Regulatory requirements change in different countries. To market a medical device internationally, you must speak the language of each market. And you must get your product certified to each market’s requirements.
To do this, you need specialist medical translators. We have in-depth knowledge of the languages we translate. We also understand the clinical application and technical documentation of medical devices. And we’re up to date on the compliance requirements of our country. Put simply, if your life sciences company wants to enter a new market, you need medical device translation services. Which is okay, since you’ve landed in just the right place.
Who are medical device translation services for?
As medical translators, we produce translations for the entire medical devices industry. Life sciences companies are a typical client we work with. But so are the healthcare professionals who implant, use, or prescribe devices. Depending on the documents, we even create translations for the end patient.
Clearly, these clients all have different needs and levels of understanding. So consider using the same translator or translators for your entire product documentation. And not just for your technical and regulatory documents. But for your marketing documents as well. Working on every document lets us see your device from every angle. This ensures the best quality. It also helps us adapt the language of our translation services to your reader.
3 phases when medical device translations are critical
Medical device translation services are needed throughout your product’s life cycle. But there are 3 phases when they become critical.
- Clinical evaluation
To market a high-risk medical device, you need clinical trials to get your product certified and support your marketing claims. Sometimes, you need these clinical findings translated into another language or languages.
- Regulatory approval
Before marketing any medical device in the EU, companies must get their product certified. This is good. Compliance with regulatory requirements helps to ensure the safety of patients. But it is a complex process for medical device companies and involves a lot of documents. And if your markets speak different languages, the process only gets more complex. Top-quality translations make all the difference to your regulatory approval.
- Market entry
The third big step in a medical device’s life cycle is market entry. Obviously, people won’t buy your device if they don’t understand your technical, regulatory, clinical, and marketing materials. In the translation world, we call translating for specific markets “localization.” This is when your global documents are adapted, or “localized,” to each market. Localization tweaks your documents to the local linguistic, cultural, and regulatory landscape.
What kinds of medical device documents can be translated?
Any and all documents, to be honest. Specifically, you may need translations of:
- Clinical findings and technical documentation for CE marking and regulatory compliance
- Instructional documentation for healthcare professionals
- User manuals and other patient-facing materials
- Marketing content
In practice, specialists like us translate websites, promotional videos, labeling, instructionsforuse, manuals, objectionhandlers, clinicalstudyreports, and more. Not sure we can translate your document? Just ask.
How do you ensure the quality and accuracy of a medical device translation?
Translating medical device documentation is a detailed, complex process that is best entrusted to a professional. Here’s a peek at some factors that go into our top-quality medical device translation services:
Sandrine: “As always, you need to have a handle on all the linguistic nuances of the language of the document you are translating. And of course, you also need excellent writing skills in the language you translate into. Having these 2 qualities helps me pick up on mistakes or confusing passages in the source text. I then remove these as I translate. This makes the language of my translation as clear as possible to the intended reader.”Sophie: “It’s really important to have a very clear idea of who is going to read the document. Personally, I like to imagine the doctor, healthcare specialist, or patient sitting in front of me as I speak to them and try to persuade them [of the merits of the device]. I make extra sure my translation is accurate and contains no ambiguity. When we translate marketing content for medical devices, we often give our translations several readthroughs. This is the best way to ensure the quality is right up there.”
The tricky case of translating marketing content for medical devices
We may be medical translators. And you are probably in healthcare. But when we translate marketing content for a medical device, what we produce is not a medical translation. It’s a marketing translation.
What makes a good marketing translation? Well, it must speak directly to the healthcare professional, patient, or management personnel it is intended for. It must focus on their needs and problems. It must use language they can understand and identify with. Above all, a good marketing translation must engage the reader’s emotions.
That said, there are strict regulatory requirements in France and other European countries on what is accepted in marketing materials for a medical device. You can only make “claims” you can back up with clinical evidence. For example, consider the implications between claiming your product is “the best” or just “one of the best.” And even then, you must be able to prove it.
A good translation of your product’s marketing materials must:
- Clearly identify the purpose of the device
- Clearly indicate who the product is for
- Be transparent about the safety risks of using the device
- Not give any false impression as to the diagnostic or therapeutic outcome
It’s tricky to get the marketing style right without overstepping these narrow regulatory boundaries. As Sophie mentions above, we read through our medical device translations multiple times. One advantage we have at pro re nata is that we work as a pair. This helps us double-check every aspect of our medical device translation services before delivery. Which in turn ensures your technical, regulatory, and marketing materials are of the best quality first time, every time. Get a custom quote for your medical device translation.
Image by Daniele Liberatori from Pixabay