Biological Evaluation
At Medalps, we manage the entire biological evaluation process in accordance with the ISO 10993 series — from defining the strategy (BEP) to compiling the final Biological Evaluation Report (BER), including toxicological risk assessments and the coordination of any necessary testing.
It all starts with... Strategy
Are you a medical device manufacturer facing one of the following situations?
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Preparing an initial regulatory submission
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Modifying your manufacturing process or materials
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Addressing nonconformities or audit findings
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Updating your documentation to align with evolving standards
Medalps offers expert support to help you build and document a robust biological safety strategy for your medical device.
A tailored, risk-based approach
We guide you through the key steps of biological risk assessment in accordance with ISO 10993-1 and related standards:
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Development of a Biological Evaluation Plan (BEP)
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Chemical characterization of materials and process residues (ISO 10993-18)
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Toxicological Risk Assessment (TRA) of extractable and leachable substances (ISO 10993-17)
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Selection and supervision of biocompatibility testing (in vitro / in vivo)
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Final Biological Evaluation Report (BER)
Modular services adapted to your needs
We support your project at all levels, from strategy to execution:
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Development of the Biological Evaluation Plan (BEP)
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Selection of suitable laboratories for chemical characterization
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Definition of test strategy: product grouping, worst-case selection, extraction conditions, protocol and report review
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Review and interpretation of chemical and biocompatibility test results
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Conducting Toxicological Risk Assessments (TRA)
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Laboratory selection and planning of biocompatibility testing
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Compilation of the final Biological Evaluation Report (BER)