Built for a Global Market
OrthoPulse is a first-of-its-kind orthodontic PBM device built for consumers. PCS developed OrthoPulse to achieve regulatory approval for the international markets targeted by Biolux Research. Our team developed OrthoPulse to meet and achieve requirements for FDA approval, Health Canada Medical Device Licensing, and the European CE mark. OrthoPulse passed on all fronts, enabling Biolux Research to scale their business to both domestic and international markets.