Precision Engineering
for FDA Compliance.

Specialized 510(k) regulatory strategy for the next generation of medical device innovators.

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Core Competencies

FDA 510(k) & De Novo Submissions
Predicate Device Strategy
eSTAR Dossier Preparation
Pre-Submission (Q-Sub) Management
Technical Performance Data Review
Quality Management Systems (QSR)
510(k) eSTAR Class II Q-Sub PMA