Carina Hjorth

Presentation:

I work as a translator and consultant in medical devices regulatory affairs since 1998, in particular with dental products. My experiences as a consultant with close contact with manufacturers have given me good understanding of the use of many products and of the terminology of standards and regulatory legislation applicable to medical devices such as the medical devices regulation (MDR) and EN ISO 13485. My key areas in translation include most of the documentation expected for medical devices such as brochures, instructions for use, quality agreements and more.