Drug and medical device registration

UA Biobank as seasoned partners, we expedite your product’s market launch leveraging our hands-on approach and deep knowledge in regulatory affairs and quality management. We handle approval and compliance documentation for medical devices, quality management system (QMS) implementation, and provide support throughout the entire product lifecycle, ensuring ISO 13485 compliance and adherence to local laws.

Our auditor and technical document reviewer teams are ready to examine your QMS, offering mock or internal audits. We will ensure the reliable completion of your development project through our test laboratory and certification body network. The up-to-date knowledge, acquired through our work in IEC standards task groups, will be at your disposal.

We provide more than mere consultancy – our involvement in the daily operations of our sister company, ASK Health enables us to quickly understand your company’s challenges.