"For your peace of mind: ISO 13485-compliant medical translations"
Specialized medical translations
Medical translation is a particularly sensitive field of scientific translation, which is why AbroadLink Translations offers medical translation that complies with the ISO 13485 quality standard and we issue a translation certificate signed by our medical translators at your request.
Medical translation has some key elements that makes it different to other types of translations. It involves different levels of quality control, knowledge of the subject matter, types of documents to be translated and controls established by in-country laws. The importance and sensitivity of documents, whether they are medical records, toxicological reports, instructions for use of medical devices or package leaflets, require the utmost professional diligence. There is no room for confusion or mistakes.
You may be aware that medical translation is one of the most demanding translation disciplines and implies a great responsibility, both moral and legal. This is why AbroadLink Translations raises the standards of translator selection established in the ISO 17100 translation services standard through our certification in the ISO 13485 standard. We provide you with real medical translation specialists, many of whom have academic training and practical experience in various medical, pharmaceutical and life science specialties such as anesthesia, biostatistics, biopharmacy, biophysics, molecular biology, clinical biochemistry, cardiology, intensive care, dermopharmacy, diagnostics and electrodiagnostics, endocrinology, endoscopy, pharmacotherapy, drug formulation, gynecology, hematology, immunology, microbiology, nutrition and dietetics, dentistry, ophthalmology, oncology, orthopedics, parasitology, otolaryngology, pharmaceutical chemistry, toxicology or urology, among others.
Whether you are a biotechnology company, a multinational pharmaceutical company, a medical device manufacturer or a research and development company in the clinical field, you will be able to enjoy medical translations with the utmost accuracy at AbroadLink Translations.
Medical translations under ISO-13485
Since November 2018 AbroadLink has added the ISO-13485 international certification on medical devices to the ISO-9001 and the ISO-17100 on translation services. As a company established in the European Union our implementation of ISO-13485 includes the requirements set out in European legislation in Regulation (EU) 2017/745 on medical devices as well as in Regulation (EU) 2017/746 on in-vitro medical devices, incorporating the recommendations set out in the MEDDEV guidelines regarding the translation procedure.
Our aim is to offer a reliable and integrated medical translation service. If you are a medical device manufacturer we can help you to export your products within Europe with the guarantee of complying with the legislation. Also if you are importing products from China or any other country, your translations of manuals, instructions for use and labelling will comply with European legislation and you can easily test them thanks to our certified services. But we go further, if you ask us to do so we will send you a certificate of accuracy of the translation issued by our medical translators.
Translations always by native translators
AbroadLink Translations has a team of professional translators, editors and proofreaders with experience in the health and medical sector. In some cases, we work with doctors who have been retrained as translators or other professionals trained in the medical field.
We offer our clients a flexible translation process for content related to medicine and all fields of health. You can benefit from translations that comply with the most demanding standard on translation, the ISO-17100 quality standard, which includes a review by a second independent professional and always under the ISO-13485 standard.
Language technology at the service of the health and medical sectors
The most professional results at competitive prices can be achieved through the use of appropriate language technology. AbroadLink Translations makes use of an advanced translation management system integrated with software for the creation and maintenance of exclusive databases for each of our clients. Thanks to our automated management system, we can ensure maximum consistency and the reuse of previous translations and offer you more competitive prices.
- Patents and associated documents
- Test report
- Regulatory audits
- Clinical trial protocol
- Security reports
- Medical records
- Product labels
- Annual Report
- Informed consent forms
- Web sites
- Case Report Forms
- Insert labels
- Advertising brochures
- Patient questionnaires
- Correspondence with IRB
- Description of the manufacturing process
- Materials for public information campaigns
- Pharmacological studies
- Mailing campaigns
- Laboratory report
- Instructions for use
- Reports of serious complications
- Registration requirements User interface
- Toxicology reports
- Training materials
- Online help system