At AssuraPath Consulting, we specialize in quality and regulatory solutions for the medical device and in vitro diagnostic industries. Our team brings deep expertise in quality management systems, global regulatory compliance, auditing, design controls, risk management, and validation. We combine practical, risk-based strategies with a commitment to regulatory excellence, helping companies of all sizes confidently meet FDA, ISO 13485, IVDR, and MDSAP requirements. From startups to global manufacturers, AssuraPath is the partner you can rely on to stay compliant and move forward—faster and smarter.
