Scientific support for biological evaluation and biocompatibility according to ISO 10993.
Request a ConsultationBiological evaluation is a risk-based process used to assess the biological safety of medical devices throughout their lifecycle. Rather than relying solely on laboratory testing, ISO 10993 promotes a comprehensive evaluation that integrates material characterization, toxicological risk assessment, literature evidence and, where necessary, biological testing.
TOXENTRA provides independent scientific support for manufacturers throughout the biological evaluation process. Our approach combines current scientific evidence, regulatory expectations and internationally recognized standards to help demonstrate the biological safety of medical devices while avoiding unnecessary testing whenever scientifically justified.
Whether you are developing a new device, updating an existing product or preparing regulatory documentation, we provide tailored scientific solutions aligned with ISO 10993 and applicable regulatory requirements.
Development of risk-based Biological Evaluation Plans defining the biological endpoints, evaluation strategy and supporting evidence required throughout the product lifecycle.
Preparation of comprehensive Biological Evaluation Reports integrating toxicological, biological, chemical and clinical evidence in accordance with ISO 10993-1.
Identification of missing data, documentation gaps and additional evidence required to support regulatory compliance.
Scientific evaluation of material composition, extractables and leachables based on ISO 10993-18 principles.
Health risk assessment of identified chemical constituents using internationally accepted toxicological methodologies.
Critical review of published scientific evidence to support biological safety and reduce unnecessary biological testing where appropriate.
Development of science-based testing strategies considering device type, intended use, duration of contact and regulatory expectations.
Scientific support in planning and coordinating biological testing with accredited laboratories.
Preparation and review of biological evaluation documentation for regulatory submissions.
Deep familiarity with the ISO 10993 series, EU MDR 2017/745 and FDA requirements for biological evaluation.
We prioritize existing data and literature evidence to reduce unnecessary animal and laboratory testing.
Objective, science-first recommendations, free from commercial testing-lab incentives.
Experience supporting submissions across multiple regulatory jurisdictions.
A Biological Evaluation Report (BER) is a scientific document prepared in accordance with ISO 10993-1 that demonstrates whether the biological safety of a medical device has been adequately assessed. The report integrates available biological, chemical and toxicological information to determine whether the device is suitable for its intended clinical use.
ISO 10993 should be considered whenever a medical device comes into direct or indirect contact with the human body. The extent of biological evaluation depends on the device's nature, duration of contact, materials, manufacturing process and intended clinical application.
Not necessarily. ISO 10993 follows a risk-based approach. In many cases, existing biological data, chemical characterization, toxicological risk assessment and published literature may adequately demonstrate biological safety without conducting additional laboratory testing.
Yes, under appropriate circumstances. When sufficient scientific evidence and equivalent material information are available, a well-documented literature evaluation combined with toxicological assessment may reduce or eliminate the need for additional biological testing, provided this approach is scientifically justified and compliant with regulatory expectations.
A Biological Evaluation Plan (BEP) defines the strategy for evaluating biological safety, while a Biological Evaluation Report (BER) documents the assessment process, supporting evidence and scientific conclusions regarding biological safety.
TOXENTRA provides scientific support throughout the biological evaluation process, including Biological Evaluation Plans (BEP), Biological Evaluation Reports (BER), ISO 10993 gap analyses, toxicological risk assessments, literature evaluations and regulatory documentation tailored to project-specific requirements.
Tell us about your device and we'll recommend the right evaluation strategy — testing-based or literature-based.
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