About Us
QAEC Limited is a medical device and in vitro diagnostic consultancy with expertise in regulatory affairs and quality assurance, established in 2016 by Charles (Ed) Spearpoint.
Charles is a seasoned professional with decades of extensive expertise in global medical device regulation and quality projects, supported by a solid grounding in industry. He has managed all medical device classifications from Class I to Class III, including active and implantables, Software as a Medical Device (SaMD), and IVDs. With his vast expertise, Charles leads QAEC Limited.
As a consultancy, we specialise in regulatory compliance and quality assurance in various markets worldwide. Our client base is extensive, as are their products. We have successfully supported them through the complex regulatory landscape to meet their notified body requirements and MDR regulations.
We navigate the regulatory complexities of product life cycles, from development to commercialisation and distribution, ensuring compliance, enhancing patient safety through clinical evaluations and fostering innovation.
Our services extend beyond conventional consultancy, as 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 in meeting UK MDR 2002, MDR 2017/745 and IVDR 2017/746.
Our commitment to excellence ensures your products not only meet regulatory standards but also set new benchmarks in healthcare quality.
We promote manufacturing excellence and have collaborated with leaders in life sciences, navigating regulatory challenges and driving quality and innovation through MDSAP, SaMD, ISO 13485, ISO 9001 and CE UKCA Marking.
We provide expert support to UKAS laboratories through supporting ongoing audits and assessments to ISO/IEC 17025 and ISO 9001.
Innovation and International Market Access
We specialise in addressing regulatory challenges and providing expertise for a growing range of new, innovative medical devices and in vitro diagnostics worldwide. We develop easy-to-understand processes and quality documentation for companies, helping them take multiple devices to market every year, including your distributors.
Our focus is on consistently putting our clients’ needs, timelines, and deliverables first to solve regulatory challenges efficiently. We understand the importance of running a business while navigating regulations, and we are always ready to help you meet compliance requirements and get your device to market.
As experts in navigating the complex world of regulations, we can help you develop innovative solutions and remain compliant. We can simplify your internal processes and ensure that you deliver safe and effective medical devices that meet all the necessary harmonised standards.
Contact us today to discuss your needs at +44 (0)1452 341913 or email us at enquiries@qaeclimited.co.uk. We are passionate about contributing to the delivery of safe medical devices, supporting healthcare systems, and enhancing patient outcomes.
LET’S CONNECT
If you would like to find out more about our range of services or have a question you would like to ask us, we are here to help.
