Identify Conformity Route
Implement
Conformity
Requirements
Appoint Brazialian Registration Holder
for Non-Brazilian Manufacturer
ANVISA Assessment
Audits and technical documentation assessment
Ready to sell
Start commercalization of your product
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 771/2022 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 771/2022, 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.
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 771/2022, 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.
