Serving the fields of medical technology, diagnostics, pharmaceuticals, and other life sciences
ADAPT is a leading translation and localization company in the fields of medicine, medical devices, pharmaceuticals, and life sciences. Within this sector, our teams of project managers, translators, and proofreaders are specialized in diverse fields of expertise, particularly
- medical imaging
- wound care
- food analytics
- veterinary medicine
- in-vitro diagnostics
- diabetes care
- clinical chemistry
The provision of user or patient information in the local language(s) of a market is a legal requirement in the vast majority of countries. In the European Union, for instance, these requirements are based on the new Medical Devices Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR), that have replaced the former EU directives (MDD, IVDD, AIMD) in March 2017.
Growing translation requirements in laboratory diagnostics, veterinary medicine and analytical sciences
Similarly, the scope of veterinary medicine has developed considerably in the past years, which has led to a growing number of new veterinary products particularly in the field of laboratory diagnostics. Also, ever-growing labeling obligations for food or cosmetic products boost the demand for translations in laboratory analytics.
As the law typically regards user information to be part of a medicinal product, the translation of patient information, clinical studies, and other safety-critical medical texts requires a particularly high level of quality, transparency, and accountability, quite comparable to the manufacturing of the medical device or pharmaceutical product itself. That’s why we insist not only on highly qualified translators but clearly defined and documented processes based on ISO 14971 risk analysis and risk management criteria, and why we employ a Quality Management System modeled after the ISO 13485 standard for manufacturers of medical products. All the relevant processes are set forth in binding Standard Operating Procedures (SOPs).
Interested in learning more? Contact us for further information or to obtain a no-obligation quote for the translation of your package inserts, patient information leaflets, manuals, user instructions, clinical studies, marketing materials or translations of any other product literature.