I’m Nataliya Nedkova, a life sciences translator, linguistic validation consultant, and the founder of NN Translations – a boutique company I started in 2010 to bring more care, clarity, and precision to the translation of medical and regulatory content.
Over the years, I’ve specialized in medical device translations, regulatory documentation, and linguistic validation for clinical trials, always guided by one core principle: ensuring regulatory compliance, conceptual clarity, and patient safety.
Together with my dedicated team, I now help MedTech companies worldwide – from medical device manufacturers and pharma companies to CROs and eCOA providers – in more than 180 languages.
Our services are certified under ISO 9001 and ISO 17100, and aligned with ISO 13485, ensuring that every process is structured, traceable, and auditable, meeting the highest international standards.
We can support you with MDR/IVDR-compliant translations, helping you submit documentation on time and evidence the process during audits and regulatory reviews.
We understand the challenges MedTech companies face when managing multilingual MDR/IVDR documentation. Here’s how we can help you stay compliant, consistent, and confident:
We translate and format documentation according to MDR 2017/745 and IVDR 2017/746, and national language requirements, helping you avoid costly rework, delays, or rejections. Our work fully aligns with MDR/IVDR Article 2 and Annex I (Ch. III), EMDN, GMDN, IMDRF, ISO 20417:2021, the ISO 18113 series (2022), ISO 15223-1:2021, WHO MeDevIS, WHO ICD-11, EDQM, FDA, and other relevant international frameworks.
All linguists are native-speaking subject-matter experts with proven experience in your device subfield – whether diagnostic, dental, or implantable devices.
Our Quality Procedure addresses any cases of poor translation quality or missed deadlines, ensuring full accountability and continuous improvement. Every project includes a translation evidence track ready for audits or Notified Body reviews.
We create and maintain client-specific glossaries, translation memories, style guides and a medical device terminology resource to guarantee accuracy and consistency across all documents and updates.
We don’t just translate — we educate and advise our clients on how to approach each project, which workflow best fits their document type and compliance level, and how to achieve the most efficient, audit-ready outcome.
We tailor each workflow to your document type and compliance level – from translation + revision to in-country or clinician review, ensuring the right balance between efficiency and accuracy.
Our structured project management ensures your translations are ready before submission deadlines, so your regulatory teams can stay focused on strategy and innovation.
We’ve developed a complete set of internal and client-facing documentation because we’re thinking about you – your needs, your challenges, and the peace of mind you deserve when partnering with a language service provider.
Each document is designed to make our collaboration transparent, structured, and aligned with your regulatory and quality goals.
Before each project, we use a Pre-Project Translation Qualifying Questionnaire to understand your requirements in detail and identify potential risks early. This ensures that every aspect –from scope and terminology to timelines and deliverables – is clear from the start.
At NN Translations, these materials are more than documents – they reflect our commitment to serve you with clarity, structure, and care, helping you achieve compliance and quality excellence without stress or uncertainty.
If you want me to advise you on your process or fix problems you are experiencing, just click below to schedule a 15-minute introductory call with me.
Would you like to learn how to master MDR/IVDR translation compliance with confidence?
You can now watch a selected excerpt from our Tremédica webinar:
“Excellence in Medical Device Translations: Mastering Regulatory Compliance Without Fear.”
