Our toxicological risk assessment service ensures compliance with Brazilian regulations, particularly RDC No. 546/2021 and RDC 751/2022. These regulations mandate rigorous evaluations of medical device materials to guarantee safety and performance. Therefore, we focus on identifying and mitigating potential chemical, physical, and biological risks according to ISO 10993 standards.
With thorough toxicological evaluations, we address the presence of harmful substances like carcinogens, mutagens, and reproductive toxins. Consequently, our assessments are crucial for both preclinical and clinical safety, ensuring biocompatibility and minimizing adverse health effects.
Moreover, our service includes comprehensive literature reviews and expert evaluations, backed by appropriate assay reports when necessary. This approach aligns with the latest ISO 10993-1 guidelines, emphasizing physicochemical characterization and expert-driven toxicological endpoints. Thus, we ensure a robust evaluation process.
Additionally, we assist in preparing technical dossiers that meet the stringent documentation standards set by ANVISA. Our experts guide you through the regulatory landscape, ensuring your devices meet all safety and performance requirements before market entry.
By leveraging our expertise, you can navigate regulatory complexities and achieve compliance efficiently. Ultimately, this ensures your products are safe and effective for patients.
Regulatory Compliance:
Ensuring compliance with Brazilian regulations, specifically RDC No. 546/2021 and RDC 751/2022, is essential. These assessments are mandatory for market entry, and failure to comply could result in penalties or market access denial.
Safety Assurance:
Toxicological risk assessments identify and mitigate potential chemical, physical, and biological hazards. This process ensures the biocompatibility and safety of medical devices, thereby protecting patient health and minimizing adverse effects.
Market Entry:
Preparing comprehensive technical dossiers that meet ANVISA’s stringent documentation standards is critical. Expert guidance through the regulatory landscape expedites market entry, ensuring that your medical devices are approved swiftly and efficiently.