Identify Conformity Route
Implement
Conformity
Requirements
Appoint US Agent
for NON-US Manufacturer
FDA Assessment
Audits and submission file (e.g. 510k) assessment
Ready to sell
Start commercalization
Navigate the complex world of regulatory affairs with our comprehensive Regulatory Service. From strategic planning to gap analysis and continuous support, ensure alignment with key regulations (e.g. 21 CFR 807) for a seamless business operation.
Sobel Consultancy’s MDR Quality Management Support offers unparalleled assistance in harmonizing your existing quality management system with the requirements of 21 CFR 820. Leveraging years of experience in medical device quality management, we ensure that your business stands tall amidst regulatory shifts and changes.
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 crucial standards required to compile your submission documentation. Tailored for medical devices, it encompasses planning, exhaustive literature reviews, product verifications, validations, and clinical data analysis. Trust our experts to deliver a comprehensive report confirming your device’s safety and performance.
An embodiment of our deep-rooted expertise in compiling robust medical device documentation. This service aligns with key regulations (e.g. 21 CFR 807), guaranteeing a comprehensive, authoritative submission files, such as the pre-market notification (510k) or premarket approval (PMA), that resonates with assurance and reliability. Trust our dedicated problem-solving approach for your needs and witness the exceptional difference we bring to your compliance journey.
Secure your place in the USA with Sobel Consultancy’s US agent service. Specialized in medical device regulatory affairs, 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 US and European regulation fundamentals to conducting meticulous toxicological evaluations. Rest assured, our training programs are tailored to meet the highest professional standards in the industry.
