This week, we are spotlighting BIVDA member NN Translations, who have recently joined BIVDA. Watch out for their exclusive webinar on translation services in December.
Supporting BIVDA Members with MDR/IVDR-Compliant Life Science Solutions
I’m Nataliya Nedkova, founder of NN Translations – a boutique translation company dedicated to supporting MedTech and life sciences organisations in managing complex multilingual regulatory requirements.
Since 2010, my team and I have been helping medical device manufacturers achieve MDR and IVDR compliance in more than 180 languages. We specialise in medical device translations, regulatory documentation, and linguistic validation for clinical trials, combining care, clarity, and compliance in everything we do.
We understand how demanding it can be to manage multilingual submissions while keeping up with MDR 2017/745, IVDR 2017/746, and national language requirements. That’s why we handle the entire translation workflow – from vendor selection and terminology alignment to quality review and regulatory formatting – under ISO 9001 and ISO 17100 certified processes aligned with ISO 13485.
Beyond translation, we educate, advise, and train our clients on the best workflows, approaches, and terminology – including how to select the right translation service providers – helping them plan efficiently, prevent delays, and submit on time with confidence.
At NN Translations, we don’t just deliver services – we build trusted partnerships that make compliance simpler and more predictable.
Read more about how we support BIVDA members here and access resources, best practices, and highlights from our Tremédica webinar on mastering MDR/IVDR translation compliance.
