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. 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 are Biocompatibility & Toxicology Testing Services?
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.
What Can Element Offer You For Biocompatibility & Toxicology Testing Services?
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.
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.
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.
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.
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
- Gas pathway particulate sampling
- Gas pathway 48-hour VOC & particulate sampling (GLP)
- USP <88> Plastics Class VI (GLP)
Your Challenges, Our Solutions
your testing partner
Complex Regulatory Demands
Our expert guidance is tailored to your device classification and target markets, providing submission-ready documentation aligned to ISO 10993, ISO 18562, and global regulatory standards.
Costly Development Setbacks
Our proactive risk assessments and strategic test planning help you avoid expensive delays by identifying appropriate testing requirements early in development and ensuring efficient regulatory progression.
Scaling Product Portfolios
Our flexible service models grow with your pipeline, integrating seamlessly with your product development cycle whether you're launching novel devices or scaling existing portfolios.
Testing Delays Stalling Innovation
Our GLP-compliant biocompatibility testing services deliver fast and reliable solutions across the entire testing process, helping you accelerate product development while maintaining compliance and safety standards.
Element Experts at your Service
Browse our experts by discipline and specialty, and explore their skills and experience.
Why Choose Element
Compliance
Our testing services align with ISO 10993 and ISO 18562 standards, delivering submission-ready documentation for global regulatory requirements.Expertise
We have a proven track record supporting hundreds of successful submissions across Class I to Class III devices.
Reliability
Our GLP-compliant laboratories maintain the highest standards of safety and regulatory compliance for consistent, dependable results.
Integration
Our flexible service models integrate seamlessly with your product development cycle, from risk assessment to regulatory submission.
Explore our global network of Labs and find your nearest location
View all locationsRelated Services
Medical Device Testing
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Orthopedic Device Testing
Element offers a comprehensive suite of testing for orthopedic devices including hip, knee, spinal and dental implants. In addition to full-service mechanical testing, our labs can assist with procedure review and development, predicate testing, and research & development.
Cardiovascular Device Testing
Element specializes in a wide range of testing for cardiovascular devices, such as stents, grafts, occluders, catheters, heart valves and pacemaker leads.
Chemical Compatibility Testing for Medical Devices, Materials, and Surfaces
Element can offer automated chemical compatibility testing that gives faster and more reliable results for medical device compatibility with medical disinfectants.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Cleanliness and Microbiological Testing
Cleaning of medical devices is a critical step for evaluating biocompatibility and controlling the microbiological load for sterilization, closely aligning to the ISO 10993-1 requirements. Patient safety is not only related to the specific materials that are being used, but also an understanding of the contaminants or residuals that can be introduced or observed during the manufacturing and handling processes.