Subacute & Subchronic Toxicity Testing
Subacute and subchronic toxicity testing is a critical component in the biological evaluation of medical devices, assessing potential adverse effects caused by repeated exposure to device materials or their extracts. These tests help identify target organ toxicity, dose-response relationships, and delayed toxicological effects, ensuring patient safety throughout the intended use period. Regulatory agencies, including the FDA, and EU MDR, require robust toxicity data as part of the ISO 10993-11 biological evaluation process. Without comprehensive subacute and subchronic toxicity testing, medical device manufacturers risk non-compliance, delayed approvals, or post-market safety issues. At Meditronics (a brand of STEMart), we provide GLP-compliant testing services to support your device's regulatory submission and market success.
Our Service
Meditronics's subacute (14-28 days) and subchronic (90 days) toxicity testing follows ISO 10993-11 guidelines, ensuring scientifically valid and regulatory-accepted results. The testing involves animal models (typically rodents) exposed to medical device extracts or implantation samples under controlled conditions:
1. Sample Preparation:
Extracts of the medical device are prepared in polar and/or non-polar vehicle based on device materials and intended use
2. Routes of Exposure:
- Injection: Intravenous (IV), intraperitoneal (IP), intrathecal (IT), intramuscular (IM), or ocular administration
- Oral/Dermal
- Subcutaneous Implantation
- Inhalation
3. Dosing & Observation Periods:
- Subacute Toxicity (14-28 days) – Evaluates short-term repeated exposure effects.
- Subchronic Toxicity (90 days) – Assesses cumulative toxicity, organ damage, and delayed responses.
4. Endpoint Analysis
- Clinical Observations: Body weight, food consumption, behavioral changes
- Hematology & Biochemistry: RBC/WBC counts, liver/kidney function markers (ALT, AST, BUN, creatinine)
- Urinalysis: Protein, glucose, sediment examination
- Histopathology: Organ weight analysis (heart, liver, spleen, kidneys, brain) and microscopic tissue evaluation (H&E staining)
Our testing methodology follows Good Laboratory Practice (GLP) standards and incorporates appropriate controls to ensure reliable, reproducible results. The comprehensive approach covers all potential exposure scenarios, providing a complete safety profile for your medical device.
Why Choose Meditronics
With decades of experience serving the medical device industry, Meditronics has established itself as a leader in biological safety testing:
✔ Tailored Study Design
We consider material composition, clinical exposure duration, contact route, and usage frequency to optimize dosing and observation periods.
✔ PhD-Level Scientists
Our team includes board-certified toxicologists with 10+ years of experience in medical device testing.
✔ Real-Time Updates
Transparent communication with weekly progress reports
✔ Post-Test Support
Assistance with regulatory documentation and audit response
Whether you are developing a Class III implant or a disposable medical tool, our Subacute & Subchronic Toxicity Testing Services provide the safety evidence needed for regulatory approval. Contact us today to discuss your testing requirements and receive a customized proposal!
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