Medical products and devices translation
Medical translation requires precision, a deep understanding of the highly specialised terminology of each specific area of medicine and up-to-date knowledge of the rules and regulations that differ from country to country.
At Ampere Translations we understand the unique challenges involved in translating medical products and devices and help medical manufacturers communicate effectively with users, regulators, and other stakeholders in multiple languages.
Types of documents we translate
- Product catalogues
- Patents
- MSDS
- IFU’s
- Installation manuals
- Device labelling
- Training booklets
Pharmaceutical translation
Submissions of centralised marketing authorisation applications (MAA) for the European Medicines Agency (EMA), regulatory correspondence, clinical trials and communications with ethics committees are some of the requirements we help international pharmaceutical companies with.
Our team of highly specialised translators make sure that your translations are compliant with the relevant requirements and are presented correctly within your operational markets.
Types of documents we translate
- GMP Documentation
- Batch Records and MBRs
- Drug testing and packaging
- Pharmaceutical proposals
- Medication instruction inserts
Clinical research translation
Clinical trials are usually carried out across multiple countries. For this reason, translation is an integral part of clinical trial processes. Pharmaceutical companies, contract research organizations (CROs) and hospitals need to comply with ethical standards and present the information to patients in a language they can understand, either written or verbally.
Ampere Translations ensures all the information from clinical trials remains confidential and that translations are accurate and compliant.
Types of documents we translate
- Clinical trials
- Deviation Reports
- Study Protocols
- Preclinical and clinical evaluation reports
- Informed Consent Forms
- Patient Recruitment Materials
- Patient Questionnaires
Rigorous quality control
- Our quality control process verifies that translations are correct and accurate across target populations and regions and have the same content validity to meet FDA and EMEA guidelines.
- We take several steps to guarantee the highest level of quality with multiple levels of quality control in line with ISO 17100:2015 Translation Services standards.
- We select our translators according to their qualifications and experience in your particular area of Life Sciences, to ensure that your documents and materials are both culturally appropriate and conceptually equivalent.
- Our linguists have access to resources, references, medical terminology and guidelines to ensure full compliance with regulatory authorities.
- A project manager will be assigned exclusively to your project to supervise its progress and guarantee timely delivery.
Our Life Sciences translators
- Our subject matter expert translators, linguists and other professionals allow us to confidently provide highly accurate translations in your field.
- We have vast experience working in a wide variety of scientific fields including biotechnology, medical devices, pharmacology and immunogenetics.
- Thanks to our cutting-edge technology, our team of translators and reviewers can easily keep the terminology consistent across translated documents and adhere to the format of your documents.
- We provide translation services in multiple languages with a focus on translation between English and the major European languages.
