Quality Management Sytems
and Audit Services
We help medical device companies build and maintain robust Quality Management Systems tailored to their needs. Whether you’re a start-up navigating ISO 13485, MDSAP, MDR, or IVDR requirements, or an established corporation seeking to integrate these standards seamlessly with existing frameworks like GMP, our expertise ensures compliance without unnecessary complexity. Our flexible support scales with your business—streamlining processes, reducing risk, and keeping you inspection-ready—so you can focus on bringing safe, effective devices to market with confidence
We provide a full range of audit services to ensure the effectiveness and compliance of your Quality Management System. Our internal audits support ongoing improvement, while readiness audits prepare your organization for regulatory inspections with confidence. Through detailed gap assessments, we identify areas requiring corrective action, and with supplier audits, we verify that your external partners consistently meet applicable standards. Whether supporting small enterprises or multinational corporations, our audit services are conducted with rigor and precision to help you maintain compliance and uphold the highest quality standards