Research & Development
Biocompatibility Studies.
Systematically demonstrate product safety. We assist medical device manufacturers in planning and conducting biocompatibility assessments—in full compliance with ISO 10993 and MDR requirements.
What biocompatibility challenges arise in medtech development?
ISO 10993 is the gold standard for biocompatibility evaluation, but it presents complex challenges:
- ISO 10993-1:2018 has changed its approach: It places much greater emphasis on literature-based assessments and material science rather than on blanket animal testing.
- Existing biocompatibility plans (BEPs) are often outdated and no longer meet the requirements of the current MDR.
- New materials or changes in processing methods (e.g., cleaning) always require new, often complex risk assessments.
- Chemical characterization (ISO 10993-18), as a powerful alternative to biological testing, is often underutilized, leading to unnecessary animal studies.
Do your Biocompatibility Plans (BEP) and Biocompatibility Reports (BER) already fully comply with the current version of ISO 10993-1:2018 and the MDR?
Our biocompatibility services.
We develop efficient biocompatibility strategies for your product that minimize animal testing and are fully compliant with regulatory requirements.
Biocompatibility Evaluation Plan (BEP)
Development of a watertight biocompatibility plan in accordance with ISO 10993-1:2018. We use a risk-based approach to selecting tests: Which tests are truly essential, and which can be replaced by literature data or chemical analysis?
Chemical characterization (ISO 10993-18)
We plan and oversee chemical characterization studies as a smart alternative to or supplement for in vivo testing. We handle the selection of suitable testing laboratories and the technical review of the reports.
Biological Testing & CRO Coordination
Professional selection of accredited testing laboratories (CROs) for ISO 10993 biological testing. We coordinate your in vitro and in vivo studies and review test protocols prior to the actual start of the study.
Biocompatibility Evaluation Report (BER)
The complete, final draft of the evaluation report. We compile all test data, the literature review, and the chemical characterization into a single document that is ready for use in the MDR dossier.
Frequently Asked Questions About Biocompatibility Studies.
What is ISO 10993, and why is it important?
ISO 10993 is the key international series of standards for the biocompatibility evaluation of medical devices. It strictly defines how biological risks posed by materials are identified and assessed. The MDR (Annex I) requires this evidence as a prerequisite for CE marking.
Is animal testing always required for medical devices?
No, on the contrary. ISO 10993-1:2018 emphasizes a strict hierarchy for avoiding animal testing: first review literature data and chemical characterization, then conduct in vitro tests, and only as a last resort, in vivo animal studies.
How does ISO 10993-1 relate to ISO 10993-18?
ISO 10993-1 is the overarching standard that defines the entire evaluation framework. ISO 10993-18 is a specific section that describes chemical characterization (extractables/leachables). Today, this characterization is often the most important basis for toxicological risk assessment.
When does a biocompatibility assessment need to be updated?
An update is required in the event of significant changes to materials, changes to manufacturing processes (e.g., new cleaning or sterilization methods), changes to patient contact conditions, or when new scientific safety data is published.
Related compliance topics.
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