Review / Preparation on Technical Documentation Files

The certification consists not just of a quality management system but also requires an appropriate technical documentation. We support you to perform a requirement analysis and create a technical documentation that fulfills the requirements. That contains an appropriate documentation structure, risk management file, clinical and biological evaluation, validation activities and product labelling. The extent will be defined together with the customer to achieve an optimal solution.

Our services with regard to technical documentation files

  • Classification of Medical Devices, In-Vitro-Diagnostics and combination products
  • Creation of technical documentation and Design dossiers (i.a. STED format)
  • Risk management accord. EN ISO 14971
  • Clinical and biological evaluation, toxicological characterization
  • Validate products and processes
Dr. Albrecht Poth Business Development Medical Devices
+49 621 718858-0 send mail

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