Compliance for medical translations
For all translations accuracy is a top priority but when translating for medical and pharmaceutical materials, where public health and safety are at stake, translations completed to the highest standard carry even greater importance.
In our previous post on adverse effects reporting, we highlighted the need for translators to have great attention to detail when translating medical research responses. Another important factor, which translators must have an in-depth knowledge of, is compliance.
Translators will have to be aware of different regulations depending on the target market of their translations. For EU countries, translations must comply with regulations issued by the European Medicines Agency (EMA) and its affiliated Committee for Human Medicinal Products (CHMP). However, countries further afield have their own governing bodies.
As regulations for the medical and pharmaceutical industry change regularly, good medical translators keep themselves informed about developments in the countries relevant to their language. For example, recent reforms to the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been implemented by the EU.
As well as compliance to the law, a highly accurate medical translation is essential for the safety of research participants as well as end users of medical devices. Medical research often seeks to trial a drug or product with a target audience. If this audience is in another country the translations will need to bridge any communication barriers, to ensure compliance with the relevant governing bodies in order to gain permission when it’s time to release the product to market. This will include compliance with confidentiality agreements, data security regulations and of course reporting any adverse effects during the research stage.
High quality medical translations
With almost 25 years in the industry, The Language Factory has provided many clients with highly technical and accurate medical translations. We understand you need qualified, mother-tongue linguists who specialise in the healthcare sector and we make sure only the most qualified and experienced translators are selected for your projects.
As an experienced agency with over 98% client satisfaction, we know our translators deliver quality, whilst following procedures and correct medical terminology. And of course they keep up to date on the latest regulations to ensure all your hard work remains compliant.
If you require expert help with your medical surveys, product labelling or medical equipment documentation, don’t hesitate to give us a call on +44 1727 862722 or send us your project details below.