FSQ Experts North America offers medical technology companies concrete and pragmatic solutions in the areas of systems engineering, risk management, quality management and regulatory affairs. We accompany MedTech development teams through all phases - from the initial requirement to market surveillance. We seamlessly integrate regulatory requirements into existing processes, promote knowledge transfer and ensure efficient collaboration between development, regulatory affairs and quality assurance. The expertise of FSQ Experts extends to ISO 13485, ISO 14971, IEC 60601-x, IEC 62304, IEC 62366-1 and other regulatory requirements set out in MDR, IVDR and 21CFR820. Our customers rely on our hands-on approach because it strategically builds technical documentation, accelerates approvals and ensures long-term compliance. We keep our finger on the pulse of the industry, attending leading MedTech events and sharing the latest findings directly with our customers - often before they become standard. This creates long-term partnerships that drive innovation