Biocompatibility Testing for Safer Medical Devices
Even the most innovative medical device can fail if it triggers an unintended biological reaction. That’s why biocompatibility testing is a critical part of the regulatory approval process. At Medivdpharma (MIP), we help you prove your device is not only effective—but also safe for patients.
Our Approach
Guided by ISO 10993-1 and FDA biocompatibility standards, we support the full biological safety evaluation process. From early planning through final reports, our team and partner labs ensure compliance and reduce regulatory risk.
We cover every key component:
- Biological Evaluation Plans – Clear strategies tailored to your device.
- Chemical Characterization – Identifying materials and potential risks.
- Biocompatibility Testing – Laboratory studies across multiple endpoints.
- Toxicological Risk Assessment – Expert analysis to confirm safety.
Testing Capabilities
Through our partner laboratories, we offer a full suite of ISO 10993 tests, including:
- ISO 10993-5: Cytotoxicity
- ISO 10993-3: Genotoxicity
- ISO 10993-4: Hemocompatibility
- ISO 10993-6: Implant Testing
- ISO 10993-23: Irritation
- ISO 10993-10: Sensitization
- ISO 10993-11: Systemic Toxicity
Why Choose MIP?
We go beyond testing—we help you use biocompatibility data strategically to keep your device on track for approval. Our services include:
- Evaluating new devices or design changes.
- Assessing the impact of new suppliers or processes.
- Conducting gap analyses of existing biocompatibility files.
- Preparing clear, regulator-ready reports.
