Complete and optimize your technical documentation and quality management system

The IVDR requires full disclosure on design, production and quality testing by manufacturers. This makes it crucial to update existing technical files to meet the new structure and content demanded by IVDR Annexes II and III. Also, it is important to comply with the new general safety and performance requirements of Annex I. Another new key requirement is to create and maintain a robust, adaptive and effective quality management system. Yet, evaluating existing files and closing gaps in the technical documentation and quality management system can require high resource investments from your organization. Benefit from our TechFile Factory and quality management services to make sure your technical documentation and quality management system meet the regulatory demands.

Overview about the requirements for manufacturers on the conformity assessment of IVD devices

Need help in building and optimizing your technical documentation or your quality management system?

Take advantage of our services:

  • Gap analysis of technical documentation and quality management systems considering relevant documents and records
  • Implementation of software lifecycle processes according to IEC 62304:2006 and IEC 82304:2016 including software development (validation and cybersecurity) and compilation of technical documentation
  • Implementation of the unique device identification (UDI) system for IVD devices in accordance with IMDRF UDI Guidance IMDRF/UDI WG/N48 Final:2019
  • Outline of inconsistencies and nonconformities and strategy development to ensure compliance
  • Rewriting and compilation of documentation for the assembly of compliant technical documentation
  • Strategic consultancy to identify the least burdensome approach
  • Planning and implementation of quality management systems addressing European and international requirements (e.g. MDSAP)
  • Implementation of relevant requirements from Annex I, II and III of Regulation (EU) 2017/746, ISO 13485, RDC 16/2013 and 21 CFR Part 820 QSR (quality system regulation)
  • Communication with notified bodies and regulatory authorities
  • Trainings and workshops on technical documentation and quality management systems

Please contact us if you want more information or a non-binding offer on our TechFile Factory and Quality Management Services.