DBG TetraKom Company
Medical Devices – In-vitro Diagnostics – Pharma
We are used to work together with globally acting Medical Device and Pharmaceutical Companies in international environments.
About us
Since more than 25 years we help international legal manufacturers of MDs/IVDs and pharmaceutical companies with combination products portfolio to bring their products to market.
Our expertise
- R&D – GSPR compliant Technical File, Usability, Risk Management File, Biocompatibility, Clinical
- Quality – optimise processes to meet relevant regulations and standards.
- Regulatory – create and submit dossiers, that provide evidence for patient safety and efficacy of products.
- PRRC and EU Rep – contact person to Authorities regarding compliance of technical file, post-market activities, e.g. update of clinical data and change management.
