Biocompatibility & Toxicity Testing

Biocompatibility & Toxicity Testing evaluates how materials, medical devices, chemicals, coatings, and drug-device products interact with biological systems. These studies assess cellular compatibility, irritation potential, systemic toxicity, sensitization, hemocompatibility, chemical safety, and in-vivo biological response, ensuring compliance with FDA, ISO 10993, USP, and global regulatory frameworks.

At Materials Metric, we provide a comprehensive suite of in-vitro, chemical, and in-vivo biological evaluations, enabling clients to de-risk products early, support regulatory submissions, and accelerate safe product development. Our services bridge chemical characterization, toxicology, biological assays, and risk assessment, delivering a complete biological safety profile.

Cytotoxicity Testing

Cytotoxicity Testing evaluates whether materials or their extracts cause cell death, reduced viability, or morphological damage according to ISO 10993-5 standards. Materials Metric performs high-sensitivity cytotoxicity assays with precise quantification and expert biological interpretation to ensure rapid and reliable biological safety screening.

Sensitization & Irritation Testing

Sensitization & Irritation Testing assesses allergic responses, immune activation, and tissue irritation potential in accordance with ISO 10993-10. Materials Metric provides modern in-vitro irritation and sensitization models supported by scientifically defensible analysis for FDA-aligned risk evaluation.

Hemocompatibility & Blood Interaction Studies

Hemocompatibility Testing evaluates hemolysis, coagulation, platelet activation, and complement pathways to determine a material’s safety for blood-contacting applications. Materials Metric conducts comprehensive ISO 10993-4 aligned blood interaction studies with clear interpretation of clotting, thrombogenicity, and immune responses.

Chemical Characterization & Extractables/Leachables

Chemical Characterization & E/L studies identify and quantify extractable and leachable compounds using mass spectrometry, chromatography, and spectroscopic profiling per ISO 10993-18. Materials Metric delivers full chemical characterization workflows with detailed toxicological relevance to support FDA submissions and biological risk assessments.

In-Vitro Toxicology & Cellular Function Testing

In-Vitro Toxicology evaluates cellular viability, metabolic function, oxidative stress, inflammatory markers, apoptosis, and proliferation under material exposure. Materials Metric applies advanced cell-based models to generate mechanistic toxicology data that informs material safety, function, and biocompatibility.

Dental & Implant Material Evaluation

Dental & Implant Material Evaluation investigates surface chemistry, corrosion resistance, osseointegration behavior, and tissue compatibility of dental biomaterials. Materials Metric integrates chemical, mechanical, and biological techniques to provide complete biocompatibility insight for implantable dental systems.

Biological Risk Assessment

Biological Risk Assessment integrates chemical data, toxicology, exposure conditions, and biological test results to determine overall patient safety per ISO 10993-1. Materials Metric prepares regulator-ready BRA reports with scientifically sound rationale and gap analyses to support your biocompatibility submission strategy.

In-Vivo Studies (Implantation & Systemic Toxicity)

In-Vivo Studies assess local tissue reactions, inflammation, systemic toxicity, biodegradation, and biological integration of materials within living systems. Materials Metric supports in-vivo biocompatibility programs with ISO-aligned study design, expert histopathology interpretation, and integrated chemical + biological correlation.

Related services

To learn more about our Biocompatibility & Toxicity Testing or other testing needs, please contact us.

Frequently Asked Questions

What is biocompatibility testing?

Biocompatibility testing evaluates how a medical device or material interacts with the body to confirm it is safe for its intended use. It follows the ISO 10993 series and is selected based on the device's nature and duration of body contact.

Which tests are included under ISO 10993?

Common endpoints include cytotoxicity (10993-5), sensitization and irritation (10993-10), systemic toxicity (10993-11), material-mediated pyrogenicity, hemocompatibility (10993-4), genotoxicity (10993-3), and chemical characterization (10993-18) with toxicological risk assessment (10993-17).

How do you decide which biocompatibility tests are needed?

Test selection follows a biological evaluation plan (BEP) based on ISO 10993-1, considering device category (surface, external-communicating, implant) and contact duration (limited, prolonged, long-term). We build the plan to match your regulatory pathway.

Do the results support FDA and EU MDR submissions?

Yes. Our biocompatibility data and chemical characterization / risk assessments are prepared to support FDA 510(k)/PMA and EU MDR technical documentation.