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Regulatory

$99.00

Medical Device Regulatory Submissions Preparation including

510(k)s, De Novos, PMAs, HDEs, IDEs, Q-submissions, Breakthrough Device & STeP Designations, and 513(g)s

Regulatory strategy

Resolution of regulatory Agency deficiencies

Regulatory Agency meetings and negotiations

Medical Device Regulatory Submissions Preparation including

510(k)s, De Novos, PMAs, HDEs, IDEs, Q-submissions, Breakthrough Device & STeP Designations, and 513(g)s

Regulatory strategy

Resolution of regulatory Agency deficiencies

Regulatory Agency meetings and negotiations