Knowledge
Regulated translation raises the same questions again and again — which language versions are mandatory, what a standard actually certifies, and where a process has to be documented. This is where we answer them.
Five ways into the subject
MDR/IVDR-compliant translation
Instructions for use, labelling and technical documentation for medical devices — which language versions the regulation requires, and what a compliant process looks like.
Read more →GMP-compliant translation
Pharmaceutical documentation under GMP: what has to be traceable, and how translation fits into a validated process.
Read more →Technical articles
Regulatory changes, standards and practical experience from our daily work.
To the blog →Frequently asked questions
Certification, quality assurance, data protection, machine translation — the questions we are asked most often.
To the FAQs →Guides and e-books
Downloadable material on translation errors, machine translation and post-editing.
To the downloads →
