We are pleased to present to you our services for the development of a technical file for medical and In Vitro products for the purpose of registration in the European Union.Our experts specialize in providing high-quality consulting services in the field of regulatory support of medical and In Vitro products and have years of experience of successful work with customers all over the world.
Services are provided in three stages described in detail below:
1. Conducting an audit of the current state of technical documentation.This stage involves a thorough examination of existing documentation to confirm compliance with the Directive's requirements. The outcome is a comprehensive report featuring insightful recommendations for enhancement, standards selection, and the work plan for subsequent phase.
2. Technical file creation.The contents of technical file depend on the MED or In Vitro Directive and the specifics of the product. Could consist of product description and specification (item 1.1 of Appendix II), the quality management system in accordance with the requirements of ISO 13485, risk management file, tests, certificates issued by Notified Body and other documents. The list of technical file's documents is created at the earlier stage.

3. Product registration in the European UnionThe following works are conducted within the framework of the stage:• Signing a contract with the authorized representative in the EU accordance with Art. 11 MED and IVDR Directives.• Formation of UDI and registration in accordance with Art. 26.• Hosting the EU commission for the purpose of conducting an audit of the technical file.• Maintaining the technical file and presenting it in case of a request, supporting correspondence between regulatory agencies and the manufacturer.