ANVISA ESPR for Medical Devices in Brazil : RDC 848/2024
The Essential Safety and Performance Requirements (ESPR) serve as the backbone for ensuring that medical devices are not only effective...
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• Market Entry and Product Portfolio Strategy
• Regulatory Plans for Multi-year Regulatory Projects
• Regulatory Intelligence across Various Markets
We work hand-in-hand with you to develop a well-rounded regulatory strategy tailored to your medical device, while accounting for your product's risk classification, intended market, and other factors.
Regulatory Strategy
Regulatory Compliance
We help you ensure your medical device complies with all applicable regulatory requirements, including premarket approval, clinical trials, and quality management systems.
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Current Technical File Compliance and Gap Analysis
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IMDRF Implementation Guidance
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Technical File Due Diligence
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Labelling Gap Analysis
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Compliance Process Assistance
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Control Processes and History Files Design
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Risk Management (ISO 14971)
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Product Classification Assistance
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Documentation Assistance
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Technical File Compilation and Submission
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Data Optimisation and Regulatory Conformance Support
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In-country Sample Testing Support
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Import Permit/License Support
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Clinical Data and Document Assessment
We equip you with up-to-date information on medical device regulations to help you understand the impact of regulatory changes on your products.
Regulatory Intelligence
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