Identify Conformity Route
for NON-EU Manufacturer
Notified Body Assessment
Audits and technical documentation assessment
Ready to sell
Mark device with CE sign and start commercalization
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 MDR 2017/745 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 EU MDR 2017/745. Leveraging years of experience in medical device regulatory affairs, 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 MDR 2017/745 standards. 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 annex II of the MDR 2017/745, guaranteeing a comprehensive, authoritative technical file that resonates with assurance and reliability. Trust our dedicated problem-solving approach for your CE file needs and witness the exceptional difference we bring to your compliance journey.
Secure your place in the European Union market with Sobel Consultancy’s European Authorized Representative. Specializing in medical device regulatory affairs, we deliver timely CE marking for medical devices, strengthening your global footprint.