BiocompatibilityStudies
Comprehensive biocompatibility testing in accordance with ISO 10993 to ensure the safety, quality, and regulatory compliance of your medical devices.
Biocompatibility Study Services
Testing Directory
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200+ Tests for a Wide Range of Biomaterials
Our tests for biocompatibility are conducted on a wide range of biomaterials, medical devices and other products to ensure safety from toxins or other harmful effects. Tests include initial screenings to product release testing, along with non-clinical safety evaluations that are compliant with current global standards. Biological tests we can perform include:
- Acute Systemic Toxicity Testing
- Biodegradation Testing
- Carcinogenicity Testing
- Sub Chronic/Chronic Toxicity Testing
- Cytotoxicity Testing
- Genotoxicity Testing
- Hemocompatibility Testing
- Implantation Testing
- Intracutaneous/skin Irritation Testing
- In Vitro Irritation Testing
- Sensitization Testing
- Subchronic Toxicity Testing
Need protocol design or a custom Biological Evaluation Plan (BEP)?
Enquire for this testingWhy Biocompatibility Is Complex
To be accessed on the global marketplace, medical devices and materials that contact the human body must comply with the internationally accepted ISO 10993.
Complex Compliance Process
Test specifications depend upon:
- Type of medical device or material
- Its intended use
- Nature and duration of contact with the human body
Wide Range of Tests
Including:
- Chemical characterisation & Cytotoxicity
- Sensitisation & Irritation
- Systemic toxicity
- Hemocompatibility & Genotoxicity
Laboratory Support
Manufacturers must:
- Identify the correct testing strategy & procedures
- Fully understand how to interpret test outcomes
ISO 17025 & GLP-Compliant Testing
ISO · FDA · ASTM
Requirements met per ISO 10993
Global Expert Network
Worldwide expertise with local support
Single Point of Contact
Guidance through the entire process
Minimise Time to Market
We offer a comprehensive range of ISO 17025 & GLP-compliant testing services aligned with the ISO 10993, helping manufacturers meet the biocompatibility requirements of ISO, U.S. FDA and ASTM.
Our network of experts and laboratories delivers global expertise with local support, while a single point of contact helps you navigate global regulatory requirements successfully.
Biological Evaluation Matrix
Overview of common biocompatibility endpoints for medical devices based on device category, body contact and contact duration (ISO 10993).
Surface medical device
Body Contact Types
Contact Duration
Core Endpoints
- Physical / Chemical Info
- Cytotoxicity
- Sensitisation
- Irritation / Intracutaneous Reactivity
Extended Endpoints
- Material-mediated Pyrogenicity
- Acute Systemic Toxicity
- Sub-acute Toxicity
- Sub-chronic Toxicity
Long-term Endpoints
- Chronic Toxicity
- Implantation Effects
- Genotoxicity
- Carcinogenicity
- Reproductive / Developmental Toxicity
- Degradation
Externally communicating medical device
Body Contact Types
Contact Duration
Core Endpoints
- Physical / Chemical Info
- Cytotoxicity
- Sensitisation
- Irritation / Intracutaneous Reactivity
Extended Endpoints
- Material-mediated Pyrogenicity
- Acute Systemic Toxicity
- Sub-acute Toxicity
- Sub-chronic Toxicity
Long-term Endpoints
- Chronic Toxicity
- Implantation Effects
- Hemocompatibility
- Genotoxicity
- Carcinogenicity
- Reproductive / Developmental Toxicity
- Degradation
Implant medical device
Body Contact Types
Contact Duration
Core Endpoints
- Physical / Chemical Info
- Cytotoxicity
- Sensitisation
- Irritation / Intracutaneous Reactivity
Extended Endpoints
- Material-mediated Pyrogenicity
- Acute Systemic Toxicity
- Sub-acute Toxicity
- Sub-chronic Toxicity
Long-term Endpoints
- Chronic Toxicity
- Implantation Effects
- Hemocompatibility
- Genotoxicity
- Carcinogenicity
- Reproductive / Developmental Toxicity
- Degradation
Note: Final endpoint selection depends on device contact type, duration and applicable regulatory requirements.
Market Access Solutions & Regulatory Expertise
Optimise Time to Market
- Single-source solutions for comprehensive testing requirements
- Wide range of testing services
- Sterilization & packaging validation, electrical safety, EMC & cybersecurity
Minimise Risk & Build Confidence
- Extensive knowledge of global regulations
- A single point of contact supports you
- Processes tailored to your specific business requirements
Expert Global Partnership
- Global network of experts & laboratories
- Trusted partner for a wide range of organisations
- Excellent customer service is our standard
Independent. Accredited. Globally aligned. Choose a laboratory with the right certifications and familiarity with the regulator where your device will be marketed.
Plan Your Biocompatibility Study Today
Get expert guidance, customized study plans, and end-to-end regulatory support.