Compass Regulatory Software

Lakeside Regulatory Compass Software simplifies your regulatory journey by helping you identify predicate devices and establish the appropriate submission pathway, whether it’s a 510(k) or De Novo. Compass provides a comprehensive list of necessary analytical studies and customizable clinical study templates, you can confidently navigate comparison studies or Safety and Effectiveness Trials. Our FDA Q-sub template ensures you’re well-prepared at every step. Trust Compass to guide you towards regulatory success and streamline your laboratory test strategy and validation plan.