Quality assurance & regulatory compliance experts,
providing cost-effective consultancy services.
QAEC Limited has successfully partnered with and assisted small and medium-sized companies, as well as long-established medical device and in vitro diagnostic organisations worldwide. We have helped them navigate the evolving regulatory landscape, ensuring that their quality management systems are robust and compliant.
With decades of hands-on practical experience in the life science sector, we understand what it takes to bring new products to market and maintain compliance. From concept to market success, we provide unparalleled expertise in quality assurance and regulatory affairs, helping your products achieve their designed intended purpose.
We have managed all medical device classifications from Class I to Class III, including active and implantables, Software as a Medical Device (SaMD), and IVDs. Our client base is extensive and varied. We have successfully supported our clients through the complex regulatory landscape to meet their notified body requirements and MDR regulations as applicable.
We help ensure that your medical devices and in vitro diagnostic products adhere to the highest standards of safety and efficacy throughout every stage of product life cycle management and alignment to UK MDR, EU MDR and EU IVDR.
We have successfully helped our clients meet various international regulatory requirements across the UK, EU, USA, and beyond. Our expertise also extends to providing expert support to UKAS laboratories through ongoing audits and assessments aligned to ISO/IEC 17025 and ISO 9001 standards.
From regulatory strategy, gap analysis, risk management, QMS, CE UKCA marking, product registration, internal audits, technical file compilation, maintenance and remediation, and more. We have the expertise that you need, and pride ourselves on our flexibility and commitment to excellence and providing solutions.
Whether you need ad hoc, short-term, interim, or long-term quality or regulatory support, we can help. We offer a dedicated, flexible approach.
Find out more about our flexible approach.
Find Out More
Contact us for Medical device expert support and guidance and transition to EU MDR 2017/745.
Contact us for In Vitro Diagnostic (IVD) expert support and guidance and transtition to EU MDR 2017/746.
Broaden your reach in the medical device market with our comprehensive support from concept to commercialisation through MDSAP.
Improve your product's journey with our specialised supply chain management assistance and achieve supply chain excellence.
Transform your innovative product ideas into reality with our expert support, as we can help you bring your new product to life.
Build a robust foundation for your company with our Quality Management System expertise.
Will your medical device technical files withstand the scrutiny of a notified body assessment?
Address non-conformances swiftly with our urgent QARA expert support and advice.
Do you need quality and regulatory support for developing software as a medical device?
We have the expertise to support you and maintain your UKAS accreditation.
We can represent your business efficiently
as your UKRP.
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. We navigate the regulatory landscape to help you achieve the highest standards of quality and safety for your products in the medical device and in vitro diagnostic industry. Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.
It would be great to work together! Contact us today at +44 (0)1452 341913 or email us at enquiries@qaeclimited.co.uk. We are here to help.
Discover how QAEC Limited can help you with regulatory expertise and quality excellence.
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Limited Company Number: 10250823
Registered Address: Unit 3 Tuffley Park, Lower Tuffley Lane, Gloucester GL2 5DE
Office address:
QAEC Limited,
Kestrel Court,
Waterwells Business Park,
Quedgeley,
Gloucestershire
GL2 2AT