Ensuring Compliance and Safety for Medical Devices
At Galileo Research, we specialize in guiding your non-clinical development journey with tailored strategies and precision-driven testing. Our approach integrates the preparation of a Biological Evaluation Plan (BEP), execution of biocompatibility tests, and the delivery of a comprehensive Biological Evaluation Report (BER)—all in compliance with ISO 10993-1 series, OECD standards, and Good Laboratory Practice (GLP).
Comprehensive Biocompatibility and Performance Testing
Our state-of-the-art services cover a wide range of biocompatibility assessments essential for regulatory submission and product approval, including:
- Genotoxicity
- Reproductive and Developmental Toxicity
- In Vitro Cytotoxicity
- Implant Toxicity at clinically relevant implantation sites
- Bio-Degradation Studies
- Irritation and Skin Sensitization
- Systemic Toxicity Evaluations
- Sample Preparation and Analysis
- Toxicokinetic Studies
- Immunotoxicology Assessments
Each test is performed using the most advanced methodologies to ensure accuracy, reproducibility and adherence to global regulatory expectations.
Streamlined Support Throughout the Risk Management Process
We go beyond standard testing by embedding biological evaluations into a robust Risk Management Process, supporting your device’s compliance journey from concept to market. With our expertise:
- We review and analyze existing data to identify gaps.
- We recommend and execute the most relevant additional tests to meet your safety goals.
- We deliver actionable insights and a fully compliant Biological Evaluation Report to accelerate your submission process.