Navigate regional and global rules (FDA, EMA, MDR/IVDR, etc.), maintain quality systems, support audits.

From product concept through formulation or device design, risk analysis and prototyping.

Health economics, payer engagement, reimbursement, launch readiness.

SaMD, digital therapeutics, AI/ML, data privacy and security.

Portfolio reviews, M&A advisory, licensing, regulatory risk modelling.

We help healthcare providers navigate the ever-changing landscape of medical compliance.