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.
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Navigate the complex world of regulatory affairs with our comprehensive Regulatory Service. From strategic planning to gap analysis and continuous support, we ensure alignment with RDC 751/2022 and related regulations for a seamless business operation.
Sobel Consultancy’s Quality Management Support offers unparalleled assistance in harmonizing your existing quality management system with the requirements of the Brazilian RDC 665/2022. Whether internal audits, analysis of existing processes, implementation of international standards or a helping hand with daily work? Our experts are ready and waiting.
Manage medical device risks effectively with ISO 14971-based Risk Management Support. Expert planning, comprehensive risk analysis, and effective control measures are at your disposal. A final report evaluates overall risk, ensuring safety and compliance.
Experience seamless Biological Evaluation for medical devices, meticulously aligned with ISO 10993 standards. Our all-inclusive service offers evaluation planning, material characterization, toxicological assessment and study monitoring if needed. Trust our experts to deliver a comprehensive report affirming device safety. With us, you receive the full package, eliminating any concern.
Experience our Clinical Evaluation Service, meticulously structured to align with Guia nº 31/2020. Tailored for medical devices, it encompasses planning, exhaustive literature reviews, product verifications, validations, and clinical data analysis. Ready for international markets (e.g. Europe, USA)?
Trust our experts to deliver what you need to be compliant and demonstrating your device’s safety and performance.
An embodiment of our deep-rooted expertise in compiling robust medical device documentation. This service aligns with RDC 751/2022, guaranteeing a comprehensive, authoritative technical file that resonates with assurance and reliability.
Trust our dedicated problem-solving approach what your technical dossier needs and witness the exceptional difference we bring to your compliance journey.
Our toxicological risk assessment service ensures compliance with Brazilian regulations, particularly RDC No. 546/2021 and RDC 751/2022. We focus on identifying and mitigating chemical, physical, and biological risks according to ISO 10993 standards. Our experts assist in preparing technical dossiers for ANVISA, ensuring your medical devices meet all safety and performance requirements before market entry.
Secure your place in the Brazilian market with Sobel Consultancy’s Brazilian Registration Holder.
Every foreign manufacturer needs a representative in Brazil. The representative holds the registration and represents him in vigilance issues.
Specialized in medical device representation, we strengthening your global footprint.
Unleash your potential in the complex realm of medical devices through our comprehensive training programs.
Our curriculum is designed to cater to your specific requirements, ranging from acquiring a deep understanding of RDC 751/2022, MDR 2017/745 fundamentals or conducting meticulous toxicological evaluations.
Rest assured, our training programs are tailored to meet the highest professional standards in the industry.
