QAEC Limited is an independent Consultancy with over 20 years of experience working within the Life Science industry, and we provide expertise in Regulatory and Quality for start-ups, SMEs and multi-national companies in multiple markets worldwide. Whether you need interim Quality or Regulatory support or longer, we can support you at all levels.
We offer Technical support and advice throughout the life cycle of your products, including companion diagnostics and combination products, sales and distribution, 510(k) submissions, remediation and maintenance of your Product Technical Files in meeting compliance and ensuring patient safety.
We can also support you as your UK QARA representative under Article 15 of the MDR 2017/745 and IVDR 2017/746.
Contact us today at 01452 341913 or email@example.com to discuss your requirements and how we can support you.