TOXLAB -Medical Devices
Accelerating Time-to-Market with Patient Safety at the Core
TOXLAB is committed to bringing safe and effective medical devices to market swiftly. Whether you are a manufacturer, subcontractor, or supplier, we offer comprehensive support throughout the entire product lifecycle, from concept to commercialization, including CE marking.
Our core expertise lies in biological risk assessment, ensuring your device meets stringent safety standards. Leveraging our extensive experience across pharmaceuticals, biocides, cosmetics, and chemicals, we provide unparalleled support for complex regulatory challenges.
We specialize in evaluating devices without a clear classification and borderline products, offering clarity and guidance in navigating regulatory complexities.
Let TOXLAB be your partner in delivering innovative and safe medical devices to patients.
Gap Analysis & Standard Gap Assessment
Identify Compliance Gaps, Ensure Regulatory Success
At TOXLAB, we offer expert Gap Analysis and Standard Gap Assessment services to help medical device manufacturers identify and address any compliance deficiencies in their development processes. By thoroughly evaluating your practices against the rigorous standards of EU MDR 2017/745 and ISO 10993, we ensure that your products meet essential safety and regulatory requirements, minimizing risks and accelerating time-to-market.
Comprehensive Gap Analysis Process
Our process begins with an in-depth review of your current development practices and documentation. Our team carefully compares your practices against the specific criteria set by EU MDR and ISO 10993, evaluating critical areas such as:
- Quality Management Systems (QMS)
- Risk Management Processes
- Product Testing and Validation Procedures
This thorough assessment allows us to identify any deviations or gaps in compliance, ensuring that all aspects of your device development meet the highest regulatory standards.
Actionable Insights & Practical Recommendations
Once the gaps are identified, we provide you with clear, actionable insights and practical recommendations to help address any compliance issues. Our goal is to guide you through the process of aligning your practices with the required standards, ensuring that you can efficiently overcome any obstacles to regulatory compliance.
By addressing these gaps early in the development process, we help you streamline workflows, reduce risks, and prevent costly delays. Our expert team offers step-by-step guidance on implementing the necessary changes, allowing you to stay on track and avoid disruptions in your path to market approval.
Enhancing Product Quality & Safety
Our Gap Analysis and Standard Gap Assessments not only ensure compliance but also improve product quality and patient safety. By addressing compliance gaps, you can enhance your risk management procedures, optimize product testing protocols, and improve overall product development. This proactive approach leads to smoother regulatory submissions and strengthens your product’s integrity and safety profile.
A Trusted Partner for Regulatory Success
Navigating the complexities of regulatory compliance can be challenging, but with TOXLAB as your partner, you gain the expertise and support needed to meet compliance requirements efficiently. Our team’s detailed analysis and actionable recommendations provide a roadmap for addressing compliance gaps, minimizing risks, and accelerating your path to market approval.
Ready to ensure regulatory compliance and product safety?
Contact TOXLAB today to learn more about how our Gap Analysis and Standard Gap Assessment services can help you identify compliance deficiencies, improve your development processes, and safeguard both your product and patient safety.
Toxicological Risk Assessment (TRA) of Extractables & Leachables
Ensuring Material Safety & Regulatory Compliance
At TOXLAB, we offer comprehensive Toxicological Risk Assessments (TRA) of Extractables and Leachables (E&L) to ensure the safety and efficacy of materials used in medical devices. Our TRA services are conducted in strict adherence to ISO 10993-17 guidelines, providing a scientifically sound framework for evaluating the potential risks associated with chemical substances that may migrate from device materials during normal use.
Comprehensive Extraction Study
Our TRA process begins with an exhaustive extraction study, where we simulate real-world conditions to identify and quantify potential extractables and leachables from the device materials. We conduct rigorous testing under various conditions to closely mimic the intended use of your device. This ensures that we capture a broad range of possible chemical substances that could migrate from the device during its lifecycle.
Toxicological Evaluation of Extractables & Leachables
Once extractables and leachables are identified, they undergo a thorough toxicological evaluation. We assess their potential health risks based on factors such as:
- Chemical Nature: Identifying the type of substances involved and their characteristics.
- Concentration: Analyzing the levels at which these substances are released.
- Biological Impact: Determining the possible effects on human health, considering exposure routes and potential toxicity.
This detailed evaluation enables us to gauge whether any of the identified substances pose a significant risk to patient health, and to what extent they could affect the overall safety and biocompatibility of your device.
Mitigating Risks & Ensuring Safety
Our Toxicological Risk Assessment not only helps ensure compliance with regulatory standards but also plays a crucial role in mitigating risks associated with material migration. By identifying and quantifying potential extractables and leachables, we provide a clear understanding of any safety concerns related to material interactions with biological systems. This in-depth analysis allows you to address potential risks early, ensuring your device’s safety and regulatory readiness.
Enhancing Product Reliability & Regulatory Approval
A comprehensive TRA is vital for securing regulatory approvals and demonstrating the safety and reliability of your device. By thoroughly evaluating extractables and leachables, we help you avoid costly delays and ensure that your device meets the highest standards of biocompatibility. This proactive approach strengthens your product’s market readiness, enhances its safety profile, and supports patient well-being throughout the device’s lifecycle.
Why Choose TOXLAB?
- Expertise: Our team has deep knowledge of ISO 10993-17 and extensive experience in conducting TRA studies.
- Rigorous Testing: We use advanced testing methods to simulate real-world conditions and ensure the accuracy of our results.
- Regulatory Confidence: With our TRA services, you can be confident that your device complies with industry standards and is ready for successful regulatory submission.
Ready to ensure the safety of your medical device materials?
Contact TOXLAB today to learn how our Toxicological Risk Assessment (TRA) of Extractables and Leachables can help you ensure the highest standards of material safety, enhance regulatory compliance, and safeguard patient health.
Biological Evaluation Plan (BEP)
At TOXLAB, we are dedicated to helping medical device manufacturers navigate the complex world of regulatory compliance and biological safety. Our meticulously crafted Biological Evaluation Plans (BEPs) are designed to meet the rigorous standards of EU MDR 2017/745 and ISO 10993, providing a comprehensive assessment of the biological safety of your devices throughout their lifecycle.
Our goal is simple: to ensure the safety, efficacy, and compliance of your product while protecting patient well-being.
What is a Biological Evaluation Plan (BEP)?
A Biological Evaluation Plan (BEP) is a detailed roadmap for assessing the biological risks associated with a medical device. It evaluates the device’s materials, design, and intended use to identify and mitigate any potential risks to patients, ensuring that the device complies with both safety regulations and international standards.
Incorporating the latest research and industry best practices, a BEP is critical for demonstrating a medical device’s biocompatibility, supporting regulatory submissions, and safeguarding public health.
Our Approach
At TOXLAB, we take a systematic, risk-based approach to developing each BEP. Our process begins with a deep dive into the device’s components, materials, and design to identify potential biological risks. We then assess these risks based on the intended use of the device and the potential patient exposure.
This in-depth evaluation considers factors such as:
- Biocompatibility: We assess whether the materials used in your device will cause adverse reactions such as cytotoxicity, irritation, or sensitization.
- Device Design: We examine the design for any potential risks related to long-term usage, degradation, or leaching of harmful substances.
- Patient Exposure: We consider the type and duration of patient exposure, from brief interactions to long-term implantation, and adjust the evaluation accordingly.
- Risk Assessment: Potential biological risks are prioritized based on their severity and likelihood, ensuring the most critical concerns are addressed first.
Why Choose TOXLAB’s BEP Services?
- Regulatory Expertise: With a deep understanding of EU MDR 2017/745 and ISO 10993 requirements, we ensure that your BEP aligns with the latest regulatory standards.
- Comprehensive Risk Assessment: We thoroughly assess biological risks, from material selection to device use, ensuring patient safety and compliance at every stage.
- Customized Evaluation: Every device is unique. Our BEPs are tailored to meet the specific needs of your product, ensuring a detailed and accurate evaluation.
- Streamlined Approval Process: A well-crafted BEP can help expedite the regulatory approval process, reducing time to market and minimizing potential delays.
Risk Based Methodology
At TOXLAB, we focus on identifying and mitigating the most significant biological risks first. Our risk-based methodology allows us to prioritize the evaluation of potential hazards based on their severity and likelihood, ensuring that the most critical risks are addressed while maintaining efficiency. This approach not only meets regulatory expectations but also minimizes unnecessary testing, saving you time and resources.
The Benefits of a BEP
- Regulatory Compliance: Ensure your device meets all the necessary regulatory requirements for market approval, including EU MDR 2017/745 and ISO 10993.
- Patient Safety: Our BEPs prioritize the safety of end-users, helping to prevent adverse biological reactions.
- Faster Time to Market: By ensuring that all biological risks are properly evaluated and addressed, we help speed up the regulatory approval process, reducing the time it takes to get your device into the hands of patients.
- Confidence in Your Product: A thorough BEP helps you navigate the complexities of biological risk management, ensuring that your device is both safe and compliant.
Get Started with TOXLAB
Partner with TOXLAB to develop a robust Biological Evaluation Plan (BEP) for your medical device. Our team of experts will work closely with you to ensure that all biological risks are identified, evaluated, and mitigated, helping you achieve both regulatory compliance and the highest standards of patient safety.
Contact us today to learn more about our BEP services and how we can help you move your medical device through the regulatory landscape with confidence.
Risk-Based Biological Evaluation for Medical Devices
At TOXLAB, we specialize in providing Risk-Based Biological Evaluations designed to optimize the compliance process for medical devices. Our innovative approach leverages a predicate device methodology, drawing on data and findings from previously approved devices similar to yours. This allows us to assess the biological safety of your device with greater precision, reducing unnecessary testing and accelerating time-to-market.
How Our Risk-Based Biological Evaluation Works
Our process begins with a thorough comparison between your device and existing predicate devices that have already met the regulatory standards. By analyzing biological evaluation data from these established devices, we can identify relevant safety profiles, potential risks, and performance characteristics that align with your product.
This comparison enables us to:
- Identify Biological Safety Risks: We focus on critical biological risks relevant to your device.
- Streamline the Testing Process: By referencing pre-approved devices, we reduce the need for redundant, time-consuming testing.
- Enhance Compliance: Our method ensures that your device adheres to regulatory requirements, including EU MDR 2017/745 and ISO 10993.
Benefits of Risk-Based Evaluation
- Faster Time-to-Market: By leveraging existing data, we can significantly shorten the evaluation and testing phases, allowing your product to reach the market more quickly.
- Cost-Effectiveness: Reducing the need for extensive new testing translates to lower overall costs, without compromising on safety or compliance.
- Regulatory Confidence: With our approach, we ensure your device meets rigorous safety and regulatory standards, addressing both patient safety concerns and regulatory expectations.
Why Choose TOXLAB?
With TOXLAB’s Risk-Based Biological Evaluation service, you can streamline your product development while ensuring that safety and compliance are never compromised. Our expertise in ISO 10993 and EU MDR 2017/745compliance, combined with a focus on biological risk mitigation, makes us the ideal partner for accelerating your medical device’s journey to market.
Let us help you bring your device to market with confidence. Contact TOXLAB today to learn more about our efficient and effective biological evaluation services.
Biocompatibility Study Design & Monitoring
Ensure Safety, Meet Standards, Achieve Regulatory Success
At TOXLAB, we specialize in designing and overseeing biocompatibility studies to ensure your medical devices meet the rigorous safety standards set by ISO 10993 and ISO 18562. Our comprehensive approach provides you with a clear path from study design to regulatory approval, ensuring that your device undergoes a thorough, scientifically sound evaluation for safety and effectiveness.
Tailored Study Design
We begin with a customized study design crafted to address the unique materials, design, and intended use of your medical device. Our goal is to identify and assess all potential biological risks that could arise from device interactions with human tissues, fluids, or organs. By developing tailored testing protocols, we ensure that every aspect of biocompatibility is evaluated in accordance with both your device specifications and regulatory expectations.
Comprehensive Testing & Risk-Based Approach
Our biocompatibility testing includes both in vitro and in vivo studies, depending on the nature of the device and its intended use. We take a risk-based approach to determine the most appropriate testing methods, sample sizes, and exposure conditions. This approach ensures the study design is fully aligned with the latest regulatory guidelines and industry best practices, while providing you with reliable, reproducible data.
Continuous Monitoring & Compliance
Monitoring and oversight are integral to the success of any biocompatibility study. Our team continuously tracks the progress of your study, ensuring compliance with regulatory standards and maintaining the highest levels of data accuracy and reliability. We conduct real-time data reviews and make adjustments as necessary to address any emerging issues. This proactive approach helps us identify and mitigate risks early, ensuring that your study remains on track.
Safeguarding Patient Safety & Regulatory Approval
By combining robust study design with continuous monitoring, we help ensure that your medical devices undergo a comprehensive evaluation for biocompatibility. Our process not only meets regulatory requirements but also plays a critical role in safeguarding patient safety. With TOXLAB as your trusted partner, you can navigate the regulatory landscape confidently and ensure your device’s success in the market.
Our commitment to excellence means we are dedicated to providing you with the highest level of service, ensuring your medical devices are safe, effective, and market-ready. Let us help you achieve your regulatory goals with confidence.
Biological Evaluation Report (BER)
Comprehensive Documentation for Regulatory Success
At TOXLAB, we provide detailed Biological Evaluation Reports (BERs) that thoroughly document the safety and compliance of your medical devices. Adhering to the rigorous requirements of EU MDR 2017/745 and ISO 10993, our BERs offer a transparent and exhaustive assessment of your device’s biocompatibility, ensuring that every step of the evaluation process is meticulously recorded and aligned with global regulatory standards.
Comprehensive Evaluation & Testing Review
Our Biological Evaluation Reports include a comprehensive review of all relevant biocompatibility testing, covering both in vitro and in vivo studies, as well as the results of toxicological risk assessments (TRA). We provide detailed documentation of:
- Methodologies: A clear account of the testing procedures used, ensuring transparency and reproducibility.
- Test Results: Objective and accurate data from all conducted studies.
- Risk Evaluations: Detailed analysis of any identified risks and the measures taken to mitigate them.
This comprehensive approach ensures that your device’s safety and regulatory compliance are fully documented, leaving no room for ambiguity.
Rigorous Safety Justifications & Analysis
In addition to summarizing testing results, our BERs include an in-depth analysis of safety justifications made throughout the evaluation process. This includes:
- A thorough review of potential biological risks associated with the device.
- The rationale behind the chosen testing procedures and the scientific basis for each decision.
- Clear conclusions regarding the device’s overall safety profile, supported by data and expert evaluations.
Our approach provides a thorough examination of the device’s biological safety, giving regulators and stakeholders a clear understanding of the device’s compliance with safety standards.
Streamlining Regulatory Approvals
TOXLAB’s Biological Evaluation Reports are designed to facilitate pre-market submissions and support ongoing regulatory audits. We ensure that our reports are:
- Well-Organized: Structured in a way that makes it easy to follow and understand, with clear sections for each stage of the evaluation process.
- Clear & Concise: Providing all necessary information without unnecessary complexity, helping you present your device’s compliance in a straightforward manner.
- Globally Compliant: Fully aligned with EU MDR and ISO 10993 guidelines, ensuring your device meets international regulatory requirements.
Our precise and thorough BERs help streamline the approval process, reducing time-to-market and making your regulatory journey smoother and more predictable.
Supporting Ongoing Compliance & Safety
Beyond helping with initial regulatory submissions, TOXLAB’s BERs are valuable tools for ongoing regulatory audits. By maintaining thorough, transparent documentation, you can demonstrate continuous compliance with evolving regulatory requirements and maintain your device’s safety and effectiveness throughout its lifecycle.
Why Choose TOXLAB for Your BER?
- Expertise: Our team has deep knowledge of EU MDR and ISO 10993 standards, ensuring that your BER is thorough, accurate, and compliant.
- Comprehensive & Transparent: Every aspect of the evaluation process is meticulously documented, providing clear evidence of your device’s biocompatibility.
- Regulatory Confidence: With our BER, you can be confident in your device’s ability to meet global regulatory standards, ensuring a smoother path to market approval and ongoing compliance.
Ready to ensure your medical device’s biocompatibility and compliance?
Contact TOXLAB today to learn how our Biological Evaluation Reports (BERs) can provide you with the detailed, reliable documentation you need for successful regulatory submissions and long-term market success.