Medical translation agency

Thankfully, there are strict rules for medical products. It is about people's health and that is not something we should put at risk. One of the requirements of a medical product is to have a proper manual or IFU (instructions for use). That is because misuse of medical products can be dangerous. This manual states exactly how the product can be used, when it can be used, but also when it should not be used.

In order to market a medical product in other countries as well, a medical translation is required. This is because a medical product cannot be sold without a manual in the language of the country in which it is sold. When it comes to translation, we get involved. We translate your medical texts into your preferred language.

More than just translating

As a medical translation agency, we like to add value. This applies not only to our medical translations, but also to the texts we receive. For translations, sometimes it’s the small things that matter. For example, a text sometimes states that something is available across the Netherlands. Where AI would simply translate this, we always check with the customer. This will probably need to be changed to the respective country, or even omitted altogether.

But sometimes it is more than just a minor detail. The situations below are examples from our translation assignments.

Unclarity

In one of our translations, we came across a sentence about the composition of the material. The sentence could be read in two ways. We received questions about this from our translators and quickly realised that it had been translated in different ways by the translation teams.

So, does the product contain rubber or not?

Since there are plenty of people with rubber allergies, this really does matter. This is a decision you cannot leave to AI, which can make different choices for each language. In fact, it is a decision that even our specialised medical translators cannot make. In cases like these, we know we need to contact the customer. The customer tells us what’s right and we make sure the translators translate it.

Mistake

For a different assignment, we received a question from our translators about a particular sentence in the manual. The sentence itself was fine, but what it said didn’t make sense. Is this correct? Of course, we took this to the customer as well. The customer was quick to confirm that there was indeed a mistake in the source text and was glad that the mistake had been spotted.

Inconsistency

We once reached out to a customer with the following question: Could you explain why a trademark symbol was used in some places but not in others? The customer clearly explained that they had made a small mistake.

Mistakes happen easily. We’re always happy to be that extra pair of eyes, helping not only to deliver a great translation but also to improve the source text.

Medical product certification

There are various ISO standards that manufacturers of medical products can comply with. One of these standards is the ISO 13485. This standard focuses on quality assurance. The standard is voluntary which means not every medical company is certified for it. It does signify something important, however. If a medical company is certified, you can assume that very strict quality standards apply within the organization.

Translations are not specifically mentioned in the ISO 13485 certification, but it’s certainly something worth thinking about. Every process needs clear rules to maintain quality and that includes translations. For translations, the solution is simple: work with a translation agency that is also ISO-certified. This is where ISO 17100 comes into play.

Certified translation agency

ISO 17100 outlines how the quality of translations should be ensured. This involves several measures, such as

the four-eyes principle, where at least two people review every translation. The focus here is on people. An AI or machine translation, even if reviewed by a person, is not considered to be ISO 17100 compliant;
Qualifications: the people we work with have to be qualified. This means they have completed the appropriate training. Several years of experience in the translation industry is sufficient as well;
Standardized processes: when everyone knows exactly how to act in each situation, maintaining quality becomes much easier.

At Mettaal, we undergo an annual audit to check these aspects – and that’s exactly how it should be. Certification exists for a reason. As mentioned before, mistakes happen easily. Our translators are only human after all, but our reviewers catch these mistakes. At Mettaal’s medical translation agency, we also include a technical verification step in the translation process. This prevents mistakes on our side, so for quality control you only need to focus on the other steps in the process.

Pharmaceutical translation agency

Apart from a medical translation agency, Mettaal is also a pharmaceutical translation agency. The regulations for pharmaceutical products, – medication – are even stricter than those for other medical products. In fact, each country has its own regulations. If a pharmaceutical company wants to offer a medicine in another country, several steps are required.

The company arranges for translations of the leaflet and packaging.
These translations, along with the research results of the medicine, are submitted to the pharmaceutical authority of the respective country. In the Netherlands, this is the Medicines Evaluation Board (CBG in Dutch).
The authority reviews all the information and either grants or refuses the license.

So it all starts with the translation. And naturally, its accuracy is a matter of life and death. Literally. Because a single mistake can be fatal. For example, when it comes to dosage, there is a huge difference between taking one tablet twice a day and taking two tablets once a day. But there is a lot more that can go wrong. An error in the other usage instructions or contraindications can lead to serious consequences. It might also prevent the medicine from working, which can be equally serious. On top of that, a medication with a poor translation risks not being approved. Reason enough to entrust the translation to a reliable pharmaceutical translation agency.

All medical translations

When you think of medical translations, you often think of medication package inserts, packages and IFUs. But there are many types of other medical documents that Mettaal also translates. This includes: