In today’s global economy, the need for accurate translations in manufacturing has never been greater. In some industries, such as the manufacture of medical devices, it’s not just a good idea – it’s a requirement. Operating instructions and critical information regarding safety must be easily understood in the native language of those who will be selling, using and maintaining this medical equipment.
The international marketplace is vital to the profitability of companies which manufacture and sell medical equipment, with some estimates indicating that between 25 and 50 percent of devices made in the United States are sold to foreign buyers, particularly in Europe, China, Korea and Japan. According to a recent study by Emergo Group on the medical device industry, North American medical device suppliers showed a 55% growth in international sales in the last few years, as did 51% of European firms. With this surge of international growth, it’s no surprise that the demand for quality translation in the medical device industry is exploding as well.
Just as the Food and Drug Administration is the regulatory body overseeing the manufacture, sales and use of medical equipment in the United States, other countries have their own regulatory bodies and their own specific sets of regulations and guidelines. For example, European directives such as the Medical Device Directive (MDD 93/42/EEC), the In Vitro Diagnostic Directive (IVDD 98/79/EC) and the Active Implantable Medical Device Directive (AIMDD 90/385/ EEC) aim to harmonize the differences between member states, requiring products imported by the European Union be translated into all its languages. While regulations vary from country to country, each EU nation requires the use of their country’s official language(s) for:
- Safety-related materials
- Cleaning instructions
- User instruction manuals
Other documentation may also require translation, as per local regulations, including:
- Case report forms
- Data protocols from clinical research
- Clinical study results
- Informed consent forms
- Package inserts
Medical translation requires a highly precise process. In this area, it is not enough for a translator to know the language; he or she must have specific expertise. Familiarity with the terminology, regulatory and compliance issues and processes specific to medical devices is vital. The translation must be reviewed, validated and double-checked by experts. The best way to accomplish this is through the use of a professional language services provider with staff that is knowledgeable and experienced in the area of life sciences and, particularly, in the area of medical device translation.
One way to ensure that service providers deliver quality translations is by making sure they follow national and international standards. As a member of the US delegation to the ISO Technical Committee 37 and the ASTM F43 Committee on Language Services and Products, CETRA is actively involved in developing and maintaining translation and language-related standards. CETRA is also ISO 9001:2008 and ISO 13485:2003 certified.