Our Mission
Our core mission is to assist medical device startups obtain regulatory approvals in the US or EU in the least burdensome way. As technology continues to accelerate in the areas of treatment, intervention, and diagnosis, it is imperative that they reach their intended market. To this end, we develop the best regulatory strategies to meet your organization's goals while streamlining the quality system process to ensure successful approvals.
About Us
iMedReg Solutions leverages AI and experienced talent from around the world to develop the optimal regulatory pathway and quality management system framework for your organization. Our philosophy is that complex regulatory requirements can be addressed and sustained with intelligent solutions.
How it Works
After submitting your input form, you'll receive a contract draft agreement based on the information you provided on the form. After both parties have signed the agreement (including a non-disclosure agreement), we will ask for specific inputs (e.g., the intended use of your device, technology description, labels, documents, etc.) to complete our regulatory assessment, pre-sub, submission, or gap analysis. Your input information will be returned to you along with the delivery of our services.
Our Services
1
US Regulatory Assessments
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FDA regulatory strategy
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Development or review of your Sub-Q application
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Complete 510(k) or De Novo application
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Review/ gap analysis of your existing 510(k) or De Novo application
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Labeling review and guidance
2
EU Regulatory Assessments
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MDR/IVDR Assessment
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Technical File development/ review
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Labeling review and guidance
3
Quality Management System
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Internal Audits
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Gap Analysis
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SOP development
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UDI
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DHF
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CAPAs
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Response to FDA 483 and Warning Letters