QAEC Limited, Quality and Regulatory Consulting for Medical Device Companies, cost effective global compliance standards, quality assurance, manufacturing, pharmaceutical and biotech consultancy services

WELCOME TO QAEC

QAEC Limited is a UK consultancy and we have decades of hands on practical expertise of actually working within life sciences and manufacturing.

We provide quality and regulatory expert consultancy services to medical device, diagnostic, medtech, healthtech, biotech, pharmaceutical and manufacturing companies worldwide. We have partnered with university spin-outs, start-ups, small and medium-sized companies, and long-established companies, helping them ensure compliance, streamline operations and meet global requirements.

Whether you are bringing new products to market and or want to ensure existing products remain compliant with the latest regulations, we can help with our unparalleled expertise.

We help ensure that your products achieve their designed intended purpose to meet notified body requirements and regulatory compliance, ensuring your products adhere to the highest standards of safety and efficacy throughout every stage of product life cycle management, and alignment to UK MDR 2002, EU MDR 2017/745 and EU IVDR 2017/746, and meet various international regulatory requirements across the UK, EU, USA, and beyond.

Why Choose Us?

Proven Track Record: Expertise in global regulatory standards for a variety of industries.
Customised Solutions: Tailored consultancy to meet your specific business needs.
MDR and IVDR Experts: Successful transition to MDR 2017/745 and IVDR 2017/746.
End-to-End Support: From setup and validation to ongoing audit support, we ensure continuous compliance and quality.
Our Flexible Resource: Ad hoc, short-term, interim, or long-term quality or regulatory support, we can help.

We understand what it takes to bring new products to market and maintain compliance. We have managed all classes of medical devices, from class I to class III, including active and implantables, Software as a Medical Device (SaMD), in vitro diagnostics (IVDs) to companion diagnostics (CDx). Also, laboratory management (ISO/IEC 17025 and ISO 9001) and much more. Our client base is extensive and varied.

From regulatory strategy, gap analysis, risk management, QMS, CE UKCA marking, product registration, internal audits, technical file compilation, maintenance and remediation, transition to EU MDR 2017/745 and EU IVDR 2017/745 and more, we have the expertise that you need. We pride ourselves on our flexibility and commitment to excellence and providing solutions.

Every client’s needs are unique, and we provide support and clarity tailored to your specific requirements. By partnering with us, we offer a strategic approach and commitment and to ensure your business meets the highest standards in regulatory compliance and quality assurance. Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.

Partner with QAEC Limited to learn how we can help you achieve your goals. It would be great to work together!