Toxicological Risk Assessment
Bringing a medical device to market isn’t just about innovation—it’s about proving that your device is safe for patients, meets stringent regulatory requirements, and performs as intended. That’s where a thorough toxicological risk assessment comes in.
Our expert-driven toxicological evaluations are designed to help your product comply with Brazilian regulations while protecting patient health and accelerating market access.
We specialize in delivering high-quality toxicological risk evaluations in line with RDC 848/2024, RDC 751/2022, and RDC 665/2022, as well as international standards such as ISO 10993.
Whether you’re launching a new product or updating an existing one, our team check if your device meets the highest safety standards from development to market entry.
Comprehensive, Science-Based Risk Evaluations
Our toxicological risk assessment process is built to meet regulatory expectations and provide peace of mind for both manufacturers and regulators. Here’s how we support you:
Chemical Characterization Review: We analyze substances identified and quantified during ISO 10993-18 chemical characterization, selecting those eligible for toxicological evaluation.
Toxicological Data Integration: Using existing toxicological data, including data on clinical use or human exposure, we assess substances for carcinogenicity, mutagenicity, and reproductive toxicity.
Tolerable Limits & Safety Margins: We define acceptable exposure levels and calculate safety margins based on your device’s intended use, duration of exposure, and route of administration.
Risk Acceptability Analysis: Each identified risk is assessed against established criteria to determine if it’s acceptable—or if additional testing or risk controls are needed.
Regulatory Documentation: Our team prepares all necessary documents for your technical dossier, aligning everything with ISO 10993 and Anvisa’s requirements for smoother approval.
This method makes your toxicological risk assessment both scientifically sound and ready for regulatory submission.
Why do you need this service?
Compliance with RDC 848/2024, RDC 751/2022, and RDC 665/2022 is mandatory for market approval in Brazil. These regulations, alongside ISO 10993 standards, specifically require a thorough toxicological risk evaluation for medical devices.
With expert analysis and proper integration of existing toxicity data, you can often reduce the need for unnecessary testing. Our evaluations also highlight whether further studies or risk control measures are needed, helping you plan ahead and avoid surprises during the regulatory review.
By identifying potentially harmful substances you’re actively reducing risks and ensuring biocompatibility. This isn’t just about passing a regulatory checklist. It’s about proving your device is safe for real-world clinical use, giving confidence to healthcare providers and end users.
Conducting a robust toxicological risk assessment is a critical step in your device’s regulatory journey. With our support, you gain more than just a report—you gain a strategic partner who understands both the science and the regulatory landscape.
Need Support with Your Toxicological Risk Assessment?
With clear, complete, and compliant toxicological documentation, we help streamline your regulatory submissions, making it easier to obtain Anvisa approval and get your product to market faster.
Whether you’re a startup looking to launch your first product or an established company seeking market expansion in Brazil, we’re here to guide you every step of the way.
Let our experts help you ensure safety, meet regulatory demands, and get your device into the hands of those who need it—faster and with confidence.
