Guide to Safe In Vitro Diagnostics
The new IVDR poses challenges for manufacturers: adapting technical documentation, conducting thorough risk analyses and performance evaluations, and implementing robust quality management systems are essential. Our experts accompany you from analysis to market approval:
- Regulatory consulting: Analysis of IVDR requirements and customized implementation strategies.
- Documentation & risk management: Optimization of technical documentation and performance of risk analyses.
- Clinical evaluation: Support in generating and documenting clinical evidence.
- Post-market surveillance: Establishment of monitoring systems for product safety.
With tailor-made solutions and industry experience, we ensure a smooth path through the IVDR rules for your in vitro diagnostic devices.