QAEC Limited is an independent UK Medical Device Consultancy based in Gloucestershire and provide Regulatory, Quality and Compliance support direct to companies of all sizes, from start-up to multi-national companies in multiple markets. We can help steer you through all areas of Quality Assurance and Regulatory Affairs including EU MDR 2017/745, EU IVDR 2017/746, Audits, QMS, Validation Management and transition, ISO 13485, ISO 9001, CE and UKCA Marking, Technical Files (construction, review, and product registration) and much more. Contact us today to see how we can help you. Contact: +44 (0)1452 341913 / +44 (0)7982760682 Email: enquiries@qaeclimited.co.uk