Our Service
Theproject provides total regulatory compliance through entire life-cycle of medical devices. Starting with Gate 1 (Pre-planning) then working through
Gate 2 (Pre-market) and maintaining compliance through Gate 3 (Post-market).
Gate 1
Pre-planning
Planning Strategy
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Develop a regulatory strategy for the project plan
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Determine classification of the device
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Class 1
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Class 2
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Class 3
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New product launch?
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Change to the product?
Gate 2
Pre-market
Regulatory Strategy
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Depending on the classification and regulatory strategy, we will execute the project plan
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Class 1 exempt
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Class 2 / 510k
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​Class 3 / PMA
Gate 3
Post-market
Compliance Strategy
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Unique device identification system (UDI)
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Medical device reporting (MDR)
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Recalls
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FDA audit and inspection
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Post-market surveillance
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FDA guidance notification
and standard notification