From development to post-market
At Bio Basic, we support manufacturers by offering comprehensive testing, consultancy, and post-market management services, always aligned with the most up-to-date European requirements.
Our services include:
- Microbiological testing and in vitro safety assessments, including the full set of studies required within the biocompatibility package
- In vitro efficacy evaluations, designed to demonstrate the device’s mechanism of action in accordance with the principles of the MDR
- Post-Market Surveillance studies, aimed at monitoring safety and performance over time, ensuring a compliant and sustainable product lifecycle
With a multidisciplinary team and a scientific approach that is both rigorous and flexible, we help companies bring to market medical devices that are safe, high-performing, and fully compliant.
