In addition to our global network of accredited laboratories, we conduct a range of specialized analytical and toxicological tests in-house—allowing us to deliver faster turnaround times, improved data interpretation, and full traceability. All regulatory consulting and preparation of final technical documentation is provided from the BiocompTox team located in Germany.
EN ISO 10993 – Strategic and Flexible Biocompatibility Testing
The EN ISO 10993 series is the global reference for the biological evaluation of medical devices. It defines requirements for assessing the interaction between medical devices and biological systems based on the nature and duration of contact. Crucially, there are multiple valid pathways to meet these requirements—we help you build a compliant and efficient strategy tailored to your device and its risk profile.
Our services include:
- Biological risk assessments and biocompatibility planning
- Gap analysis of existing preclinical data
- Literature-based and toxicologically justified test waivers
- Study design and coordination with global laboratories
- In-house execution of specialized chemical and toxicological analyses
- Full toxicological risk assessments (TRA) and justification reports
Whether you need full test execution or strategic input during your design validation, we provide flexible solutions that balance regulatory compliance, cost efficiency, and technical feasibility. Our experts select laboratory partners based on the regulatory needs of your target market (e.g., CE marking, FDA 510(k), PMA, or international registrations).
Expertise Across Related Biocompatibility Standards
Depending on the device category and exposure type, specific standards beyond EN ISO 10993 may apply:
- EN ISO 18562 – Required for breathing gas pathways in respiratory devices (e.g., ventilators, anesthesia circuits). We offer assessments of volatile organic compounds (VOCs), particulates, and leachables with potential inhalation toxicity.
- EN ISO 7405 – Applicable to dental medical devices. We provide biological evaluations including cytotoxicity, sensitization, and genotoxicity for intraoral exposure conditions.
We ensure full alignment with all applicable standards in your device’s Biological Evaluation Plan (BEP), helping you build robust and regulator-ready documentation.
Why Choose Us for Medical Device Biocompatibility?
- Over 15 years of hands-on experience in medical device biocompatibility and toxicology
- Strategic support for start-ups and first-time regulatory submissions
- Cost-effective and risk-based approaches aligned with EN ISO 10993
- In-house laboratory for selected analytical and toxicological services
- Collaboration with global laboratory networks based on approval region
- Technical documentation and engineering services from our side in Ludwigslust (Germany)
- Full compliance with EU MDR, FDA, and global regulatory frameworks
Whether you’re preparing your first regulatory submission or optimizing the biocompatibility testing of a new-generation device, our team delivers trusted, global support in biological evaluation, toxicological risk assessment, and regulatory documentation for medical devices. Our international network and in-house lab capabilities make us a reliable partner for manufacturers seeking efficiency, compliance, and expert insight.
Contact us today to learn how we can help you meet biocompatibility requirements and accelerate your medical device approval process.
BiocompTox GmbH
Gewerbepark (Industrial park)
Grandweg 1
19288 Ludwigslust
Germany
