Biocompatibility & Toxicology Testing Services
Element's biocompatibility and toxicology services provide fast, reliable, and compliant testing solutions that accelerate your medical device development while ensuring the highest standards of safety and regulatory compliance. For medical device manufacturers who demand precision and speed, our GLP-compliant laboratories offer cutting-edge in vitro biocompatibility testing aligned with ISO 10993 and ISO 18562 standards from risk assessment through regulatory submission.
What are Biocompatibility & Toxicology Testing Services at Element?
Biocompatibility and toxicology testing ensures medical devices are safe for patient contact and use, evaluating potential biological risks before market introduction. At Element, we provide comprehensive biocompatibility and toxicology testing services that support every stage of your product development process while maintaining device safety and efficacy. Our services help you identify and mitigate biological risks, particularly crucial for devices with direct patient contact, implantable products, and respiratory pathway devices. Unlike generic testing providers, we specialize in medical device biocompatibility, offering proven expertise across Class I to Class III devices with submission-ready documentation that meets global regulatory requirements.
What can Element offer you for Biocompatibility & Toxicology Testing Services?
Key Tests Offered
Key Tests Offered
Accelerate your route to market with our comprehensive suite of GLP-compliant testing services designed to meet regulatory requirements and support successful submissions across global markets.
ISO 10993 Biocompatibility Testing:
- Cytotoxicity (GLP)
- Sensitization testing
- Irritation testing
- Pyrogenicity testing
- Acute systemic toxicity
- Subacute toxicity
- Extractables & leachables
- Implantation effects
- Hemocompatibility testing
- Genotoxicity testing
ISO 18562 Respiratory Device Testing:
- Gas pathway particulate sampling
- Gas pathway 48-hour VOC & particulate sampling (GLP)
- USP <88> Plastics Class VI (GLP)
Components and Materials We Test
Components and Materials We Test
We test a comprehensive range of medical devices with expertise across Class I, II, and III device classifications. Our experienced scientists work with various device types including surgical instruments, diagnostic equipment, implantable devices, and combination products. We evaluate devices with different patient contact durations and pathways, ensuring appropriate testing protocols for your specific device classification and intended use.
Methods and Solutions Offered
Methods and Solutions Offered
Navigate complex regulatory requirements with our strategic approach to biocompatibility testing, from initial risk assessment through final regulatory submission. Our services integrate seamlessly with your product development cycle, providing expert guidance tailored to your device classification and target markets.
Which Labs Offer This Service
Which Labs Offer This Service
Our scientists are experienced across a range of medical device types and classifications. We operate under current Good Laboratory Practices (GLP) and maintain the highest standards of safety and regulatory compliance. Find your nearest testing location on our Locations Page.
Risk Assessment & Strategic Planning
Risk Assessment & Strategic Planning
We begin with comprehensive risk assessments and biological evaluation plans (BEDP) that identify appropriate testing requirements based on your device's intended use, patient contact, and regulatory pathway. Our strategic test planning helps avoid costly setbacks and ensures efficient progression through development phases.
Standards We Test To And Devices We Test
- ISO 10993 (Biological evaluation of medical devices)
- ISO 18562 (Biocompatibility evaluation of breathing gas pathways)
- Good Laboratory Practice (GLP) standards
- USP <88> Plastics Class VI requirements
Medical Devices
- Class I, II, and III medical devices
- Surgical instruments and tools
- Diagnostic devices and equipment
- Implantable medical devices
- Combination products
Respiratory Devices
- Breathing gas pathway components
- Respiratory device materials
- Gas pathway filters and components
Device Components
- Device materials and coatings
- Packaging materials in patient contact
- Sterilization residuals and process materials
Your Challenges, Our Solutions
Complex Regulatory Demands
Costly Development Setbacks
Testing Delays Stalling Innovation
Why Choose Element
Compliance
Expertise
Reliability
Integration
Explore our global network of labs and find your nearest location
VIEW ALL LOCATIONS
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