MEDICAL DEVICE DEVELOPMENT MANUFACTURING. EVERYTHING IN-HOUSE.
REGULATORY
Assigning regulatory expertise in-house for accurate and accelerated approvals.
VitaTek has invested in a team of medical device regulatory experts to bring an inventor's device to market with completion of all appropriate FDA approvals and processes.
Our team of regulatory experts start with an exploration phase to understand the current regulatory pathway for each individual inventor's medical device. This process includes researching regulatory standards, review of clinical study pathways; in addition to the assessment, definitions, implementation, and submissions of regulatory documentation to become FDA compliant and receive 510k clearances, PMA approvals, DeNovo approval, EU market authorizations and more.
Why choose VitaTek for Regulatory submissions and assignments?
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Establishment of Regulatory Pathways/Roadmaps
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Review of Regulatory Partners including QMS, Design History files, and Regulatory Documentations
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Clinical Study Pathways
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Creation of Submission Structures and Outlines
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Regulatory Market Authorization
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Risk Management
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Labeling & Additional Indications for Use
