Decomplix

Decomplix is a Swiss medtech regulatory and quality consultancy focused on helping medical device and in-vitro diagnostic companies obtain and maintain market access. The company provides CE marking support, regulatory strategy, quality management assistance, Swiss importer compliance support, and Swiss Authorised Representative (CH-REP) services. It also supports software as a medical device programs, including a partnered pathway to CE-certified medical device software. Decomplix appears to operate as a boutique, service-based company rather than a therapeutic product developer, serving startups through larger corporates that need help navigating EU and Swiss medical device requirements.