Chemical Characterisation & Risk Assessment
of Medical Devices
AAL Biosciences provides comprehensive chemical evaluation and toxicological risk assessment services for medical devices.
Our expertise helps innovators understand the chemical composition of their devices, identify potential hazards, and ensure global regulatory compliance. By combining ISO 10993-18 chemical characterisation with ISO 10993-17 risk assessment, we deliver actionable insights that safeguard patient safety and accelerate market approval.
With ABT-certified toxicologists registered in the UK and Europe, our assessments are trusted for precision, scientific rigour, and regulatory acceptance.
Necessity of Chemical Characterisation & Risk Assessment
Here’s why discovery and CMC testing are indispensable in pharmaceutical development:
Detects Hidden Risks
Identifies extractables, leachables, and impurities that may compromise safety.
Supports Regulatory Submissions
Provides evidence for compliance with ISO 10993, FDA, and EU MDR requirements.
Guides Material Selection
Helps designers choose safe, biocompatible materials before prototyping.
Predicts Long-Term Safety
Assesses potential toxicological impacts throughout the device lifecycle.
Enhances Product Confidence
Demonstrates a robust scientific approach to safety and compliance.
Area of Expertise
