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About Us
Your Trusted Partner in Quality Assurance & Regulatory Affairs
Founded in 2016 by Charles (Ed) Spearpoint, QAEC Limited was created to support organisations across the life sciences sector, including medical devices, medtech, IVD, companion diagnostics, biotech, healthtech, drug-device combinations, and manufacturing in meeting complex regulatory and quality requirements. Over the years, we have worked with start-ups, SMEs, and global manufacturers worldwide.
Charles is a seasoned professional and brings decades of practical expertise in global regulations and quality systems, backed by a strong foundation in life sciences and manufacturing. His vast expertise covers all device classifications, from Class I to Class III, including active and implantables, as well as IVDR Classes A to D. He continues to lead QAEC Limited with a hands-on, solutions-driven approach.
What sets us apart is our ability to translate complex regulations, including UK MDR, EU MDR, EU IVDR, FDA, and other international frameworks, into clear, actionable strategies. By streamlining processes and promoting manufacturing excellence, we help clients bring safe, effective products to market while staying fully compliant.
Our client base is diverse, but our goal is always the same: to provide trusted regulatory and quality guidance that builds long-term confidence and success.
Why Choose QAEC?
Flexible Quality and Regulatory Expertise
Whether your quality and regulatory requirements are short-term, interim, or long-term support, or you prefer a monthly retainer, we provide the tailored expertise that you need cost-effectively.
We can also act as an extension of your team, providing extra support for routine tasks and projects your team may not have the capacity or expertise, as we can fill the gaps:
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Quality and regulatory compliance tasks
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Internal audits
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Less itemised, small or large projects, e.g., outsourcing an assignment or project, a complete transition or remediation project, temporary or longer specialist on-site or remote support.
