MEDICAL DEVICE & IVD CONSULTANCY

YOUR TRUSTED PARTNER IN MEDICAL DEVICES & IN VITRO DIAGNOSTICS

At QAEC Limited, we have successfully partnered with medical device, medtech, diagnostics, and biotech companies worldwide to navigate the complex and ever-evolving regulatory landscape. We have helped start-ups, small and medium-sized companies, and long-established companies bring new products to market and ensure their existing products remain compliant with the latest regulations, through our expertise as a trusted partner in the life science industry.

Our Extensive and Flexible Consultancy Services

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, successfully supporting our clients achieve the designed intended purpose of their products to meet their notified body requirements and MDR regulations.

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 help ensure that your 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.

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