At QAEC Limited, we specialise in Regulatory and Quality consulting for the Medical Device and In Vitro Diagnostic (IVD) industry, serving start-ups, SMEs, and multi-national corporations across various markets. With decades of expertise led by Charles Spearpoint, we navigate the complexities of product life cycles, from development to sales and distribution, ensuring compliance, enhancing patient safety, and fostering innovation.Our services extend beyond conventional consultancy; we provide technical support and strategic advice across all stages of product development, including 510(k) submissions, remediation, and the meticulous maintenance of Technical Files. Our commitment to excellence ensures your products not only meet regulatory standards but also set new benchmarks in healthcare quality.In addition, QAEC Limited offers comprehensive support for laboratory setup and validation. This ensures the calibration, environment controls and verification and validation of all measuring and testing equipment, as well as Internal Audit support, all in accordance with ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories. Our holistic approach is designed to streamline your operations, ensuring your laboratories operate at peak efficiency and compliance.Let's collaborate to elevate your medical device or IVD products to new heights of regulatory excellence and patient care. Contact us at enquiries@qaeclimited.co.uk to arrange a free MS Teams consultation call to explore how our expertise can support your goals and deliverables.www.qaeclimited.co.uk