Services to Ease FDA Regulatory Compliance

PMA (PREMARKET APPROVAL)

Most Class III devices require Pre-Market Approval, or PMA. The PMA is the most stringent type of pre-market submission. To gain FDA approval, the sponsor must provide valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for the device’s intended use.

We provide complete assistance for Pre-Market Approval at highly competitive fees. Please contact us for more information.

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