Sunrise Labs’ regulatory strategy experts have led dozens of medical devices to successful clearance and market acceptance, and are well-connected with FDA personnel and policies. Work with us to define a medical device regulatory strategy that fits your business needs and vastly improves your chances for success in getting FDA medical device approval.

Typically, this work starts with a Gap Analysis to determine what has been done vs. what needs to be done/defined including:

• Device Classification
• Clinical Assessment

The output of this initial work is a brief outlining directionally the strategy and pathway, which lays a foundation for the Regulatory Plan which should include:

• Predicate analysis
• Pre-code review
• Clinical Protocol 
• Sample size evaluation

Whether you need assistance with the Pre-Submission process and are seeking guidance on how to position your key messages to the regulatory agency or are looking for someone to develop all of your submissions and interface directly with FDA on your behalf, we have the experience. Our experience extends from PreIND, PreIDE, IDE/IND, 510(k), PMA, and BLA applications in the US and CE Mark Dossiers in the EU.