Regulatory Diagnostic Consulting
At QAEC Limited, we provide specialised quality and regulatory consultancy services to support diagnostic companies in the life science industry, spanning from in vitro diagnostics (IVD) to companion diagnostics (CDx). Our tailored expertise supports university spin-outs and start-ups to SMEs and multinational companies. We help ensure that your diagnostic products meet global regulatory standards and obtain market approval smoothly and efficiently.
Our Services
- Regulatory Strategy Analysis: Comprehensive guidance on global regulatory pathways to help ensure successful market entry.
- Device Classification: Expert assistance in correctly classifying your diagnostic products under UK, EU, and US regulations.
- Technical Documentation: Creation, review, and remediation of technical files, ensuring full compliance with regulatory requirements.
- Gap Assessments: Thorough evaluations of your compliance with UK, EU, and US IVD regulations, identifying areas for amendment.
- CE and UKCA Marking: Full support for achieving CE and UKCA markings to help ensure market access across Europe and the UK.
- Quality Management System (QMS) Support: Implementation, and optimisation of QMS in line with ISO 13485 and other relevant standards.
- Auditing Services: Comprehensive internal and external audits for critical suppliers to maintain and improve compliance standards.
- Global Registrations: Assistance with global market registrations, ensuring compliance across multiple regions.
- EU IVDR 2017/746 Transition: We provide expert guidance for a smooth and compliant transition from IVD 98/79/EC to IVDR 2017/746, seamlessly integrating new regulatory requirements into your quality management system and product lifecycle. Whether you’re just starting or have already completed your transition, we can review your documentation, offer guidance, and provide advice to ensure full compliance. QAEC Limited has successfully guided numerous companies through the IVDR 2017/746 transition, ensuring compliance and market continuity. We offer tailored support at every stage.
From regulatory strategy to global registration, we provide expert support at every level of your diagnostic product’s lifecycle, meeting the specific regulatory requirements of your target markets. Whether you need regulatory assistance for your existing device or you are launching a new device, we can help.
Our consultancy services are tailored to meet your needs at competitive and cost-effective rates. Contact us today at +44 (0)1452 341913 or email us at enquiries@qaeclimited.co.uk.
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.
