Comprehensive Biocompatibility Compliance Services for Medical Devices

Biological Evaluation as per EU MDR and ISO 10993

We develop and implement thorough biological evaluations to meet the requirements of both the EU MDR and ISO 10993. Our approach combines up-to-date research with best practices to create robust evaluations that demonstrate device safety and effectiveness.

Biological Evaluation Plan (BEP)

• The BEP is a cornerstone of ISO 10993-1:2018. It serves as a comprehensive guide for evaluating a device’s biological risks, assessing its materials, design, and intended usage to detect and mitigate potential patient risks. Our team crafts systematic, risk-based BEPs that incorporate the latest scientific knowledge and Regulatory expectations, ensuring your device meets all necessary standards before market entry.

Biological Evaluation Report (BER)

• We prepare detailed BERs that provide an objective review of all biocompatibility testing, including in vitro and in vivo studies, and toxicological risk assessments (TRA). These reports offer a transparent account of testing procedures, objective data, and thorough risk analyses, ensuring that your device is fully compliant and ready for Regulatory submission.

Toxicological Risk Assessments (TRA) of Extractables and Leachables (E&L)

Chemical substances that may migrate from device components during normal use, known as extractables and leachables, pose potential risks to patient safety. We conduct thorough TRAs in line with ISO 10993-17 guidelines to assess these risks systematically:

• Substance Identification: Determining the types and properties of all extractable and leachable compounds.
• Concentration Analysis: Evaluating the levels at which these compounds are released.
• Toxicity Assessment: Assessing potential human health risks through exposure pathways and hazard profiles.

This rigorous process ensures that every compound meets the required margin of safety, safeguarding both patient health and device biocompatibility compliance.

Predicate Device Strategy

Our innovative predicate device approach leverages data from devices already approved and in use. By comparing your device with predicate devices that have demonstrated compliance and safety, we:

• Identify relevant safety profiles and risk factors.
• Reduce unnecessary testing, saving time and resources.
• Accelerate your device’s time-to-market while maintaining Regulatory integrity.

This strategy is especially valuable in today’s competitive landscape, where speed and efficiency can define market success.

Risk Mitigation & Safety Strategy

Identifying risks is only part of the solution, effective mitigation is crucial for Regulatory compliance and patient safety. We prioritize potential biological risks based on severity and likelihood, ensuring that critical concerns are addressed first. This approach not only meets Regulatory requirements but also enhances the device’s overall safety profile.

Biocompatibility Study Design and Monitoring

Every device is unique, and so are its testing needs. We create customized biocompatibility study designs that consider:

• The device’s material composition.
• Intended use and duration of patient exposure.
• Potential interactions with human tissues, fluids, and organs.

Our team ensures that testing protocols align with ISO 10993 standards and Regulatory expectations. Continuous monitoring and oversight throughout the study guarantee compliance, data accuracy, and reliable results that stand up to regulatory scrutiny.

Safety Justifications and Analysis

Our BERs go beyond reporting, they provide in-depth safety justifications and scientific rationales for every testing decision. We:

• Review all identified biological risks.
• Explain the rationale behind each test, ensuring Regulatory transparency.
• Draw clear, data-driven conclusions regarding the device’s overall safety profile.

This comprehensive approach supports smooth Regulatory submissions and fosters trust among regulators, healthcare providers, and patients.