In Vitro Diagnostic (IVD) Consultancy
Tailored Support for In Vitro Diagnostic Compliance (IVD)
QAEC Limited is the consultancy you need to help navigate the ever-changing regulatory landscape for your In Vitro Diagnostic (IVD) product, guiding it through to approval. Our expertise covers the complete IVD regulatory approval cycle. This makes us a trusted partner for start-up, SMEs, and well-established IVD companies alike.
Whether you’re developing a new IVD product or refining an existing one, our regulatory knowledge is at your disposal to help ensure your products comply with international market requirements, maintain patient safety, that your products fulfil their intended use and purposes, ensuring alignment of your technical files. We specialise in simplifying the regulatory processes, and by optimising your processes, we aim to boost your organisation’s efficiency, cut down on costs, and elevate your success rate.
QAEC Limited offers tailored consultancy services at competitive and cost-effective rates. Whether you need ad hoc, short-term, interim, or long-term quality or regulatory support, we can step in and help.
Our In Vitro Diagnostic (IVD) Consultancy Services:
- Regulatory strategy analysis
- Device classification
- Technical documentation – creation, review and remediation, monitoring and enhancements
- Gap assessments to current UK/EU/US IVD requirements
- CE and UKCA marking
- Quality management system support and implementation
- Auditing
- Global registrations
- EU IVDR 2017/746 transition
Mastering EU IVDR Regulation 2017/746 Compliance
With our expert guidance, your transition process will be smooth and compliant. Our proven track record in successfully facilitating the IVDR transition for numerous companies, ensures that your quality management system and product classifications under both IVD 98/79/EC and IVDR 2017/746 are seamlessly integrated throughout the product life cycle.
Even if you have completed the work on the transition process yourself but still have some uncertainties, QAEC Limited can still help, by reviewing your documentation and providing advice and guidance as your regulatory partner, supporting you at every level.
QAEC Limited is here to simplify the complexity of regulatory requirements for you.
Contact us for bespoke IVD Regulatory Support
Reach out to us at +44 (0)1452 341913 or at enquiries@qaeclimited.co.uk to find out how we can tailor our regulatory support to meet IVD your needs, or to learn how our services can benefit your projects and continuous improvement of your Quality Management System.
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.
