Regulatory Compliance and Absolute Terminology Fidelity in Life Sciences
In life sciences, precision is non-negotiable. Following the enforcement of the European Union Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746), medical device manufacturers and pharmaceutical enterprises face rigorous linguistic requirements under Article 10(11). Device labelling, Summary of Safety and Clinical Performance (SSCP), and Instructions for Use (IFU) must be translated into the national languages of all member states where the equipment is distributed, subject to strict Notified Body audits prior to CE marking.
Alphatrad Worldwide delivers specialized medical translations compliant with DIN EN ISO 17100:2015-05 and ISO 13485 standards. Our linguists are certified physicians, biomedical engineers, and pharmaceutical regulatory specialists with extensive experience in EMA and FDA documentation.
Comprehensive Medical & Pharmaceutical Scope
- Medical Devices & In Vitro Diagnostics: Instructions for Use (IFU), surgical manuals, device firmware strings, user manuals, and implant cards compliant with MDR 2017/745.
- Clinical Research Documentation: Clinical Investigation Plans (CIP), Investigator's Brochures, Informed Consent Forms (ICF), and patient-reported outcome measures.
- Regulatory & Pharmacovigilance: Summaries of Product Characteristics (SmPC), Patient Information Leaflets (PIL), Periodic Safety Update Reports (PSUR), and EUDAMED submissions.
- Validated Medical Terminology: Terminology locked via MeSH and MedDRA hierarchies with independent dual-blind review for critical clinical parameters.
