Independent scientific support for the safety evaluation of medical devices throughout product development, regulatory approval and post-market surveillance.
Request a ConsultationEnsuring the safety of medical devices requires a multidisciplinary, risk-based approach that extends beyond biological evaluation. Manufacturers must demonstrate that their devices are safe for their intended use by integrating toxicological assessment, biological safety, clinical evidence, risk management and regulatory documentation throughout the entire product lifecycle.
At TOXENTRA, we provide independent scientific expertise to support manufacturers in meeting international regulatory expectations for medical device safety. Our evaluations are based on current scientific evidence, internationally recognized standards and regulatory guidance, helping organizations prepare robust technical documentation and demonstrate product safety with confidence.
Whether you are developing an innovative device, updating an existing product or preparing documentation for market access, we deliver tailored scientific solutions that support regulatory compliance and patient safety.
Comprehensive toxicological evaluation of device materials, constituents, manufacturing residues, extractables and leachables to determine potential risks associated with patient exposure.
Scientific review and interpretation of published clinical evidence to support clinical evaluation activities and demonstrate the safety and performance of medical devices.
Development of science-based biological safety strategies integrating ISO 10993 principles, toxicological evidence and device-specific risk assessment throughout the product lifecycle.
Scientific assessment of raw materials, additives, colorants and manufacturing substances to identify potential toxicological concerns before regulatory submission.
Scientific evaluation of post-market safety information, literature and vigilance data to support ongoing safety monitoring and regulatory compliance.
Scientific support for identifying, evaluating and documenting biological and toxicological risks as part of the overall medical device risk management process.
Preparation and scientific review of technical documentation supporting biological safety, toxicological evaluation and regulatory submissions.
Scientific support for demonstrating compliance with applicable Medical Device Regulation (MDR) requirements related to biological safety and toxicological evaluation.
Independent scientific expertise in medical device safety.
Risk-based evaluations aligned with international regulatory expectations.
Experience in toxicological assessment and biological evaluation.
Regulatory-ready scientific documentation.
Tailored support throughout the entire product lifecycle.
Medical device safety assessment is the scientific evaluation of all factors that may affect patient safety, including materials, biological risks, toxicological hazards, clinical evidence and intended use. It supports the demonstration that a device is safe under its intended conditions of use.
Not always. Biological evaluation is an essential component of device safety, but manufacturers may also need toxicological assessments, clinical evaluation, risk management documentation and post-market safety activities depending on the device and applicable regulatory requirements.
Toxicological assessment is typically required whenever patients may be exposed to chemicals released from device materials, manufacturing residues, degradation products or extractables and leachables. The assessment helps determine whether these exposures present an acceptable level of risk.
TOXENTRA provides scientific support in preparing toxicological evaluations, biological safety documentation, literature reviews, risk assessments and regulatory-ready reports that contribute to compliance with applicable MDR requirements.
Medical device safety does not end after market approval. Post-market surveillance and vigilance activities help identify new safety information, evaluate potential risks and support the continuous demonstration of product safety throughout the device lifecycle.
Yes. We provide scientific support for both newly developed medical devices and existing products requiring documentation updates, gap analyses or additional scientific evidence to meet evolving regulatory expectations.
Medical device safety requires scientifically sound, risk-based decision-making throughout the product lifecycle. TOXENTRA provides tailored scientific support to help manufacturers demonstrate safety, meet regulatory expectations and prepare robust technical documentation.
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