In Vitro Diagnostics (IVD)
Navigating Global Regulatory Compliance with Expertise
Tailored Support for In Vitro Diagnostic Compliance
At QAEC Limited, we specialise in guiding your company through the entire Product Life Cycle with a focus on global regulatory requirements. Our expertise includes In Vitro Diagnostic (IVD) compliance, making us a trusted partner for start-ups, SMEs, and multinational corporations alike.
Whether you’re developing a new product or refining an existing one, our regulatory knowledge is at your disposal to ensure your products comply with international market requirements. This dedication not only maintains patient safety but also guarantees that your products fulfill their intended purposes.
Simplifying Complex Regulatory Landscapes
The medical device industry is fraught with intricate regulations, classifications, and standards that can seem insurmountable. QAEC Limited stands ready to simplify these complexities for you. Our approach includes comprehensive support in documentation maintenance, monitoring, and enhancements to ensure your compliance and adherence to all relevant standards and regulations. By optimising your processes, we aim to boost your organisation’s efficiency, cut down on costs, and elevate your success rate.
Mastering EU IVDR Regulation (2017/746) Compliance
Transitioning to the new EU IVDR Regulation (2017/746) expectations can be challenging, but you don’t have to face it alone. With QAEC Limited’s expert guidance, your transition process will be smooth and compliant. Our proven track record in 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.
Connect with Us for Bespoke Regulatory Support
Embark on your compliance journey with confidence. Reach out to us at 01452 341913 or enquiries@qaeclimited.co.uk to explore how we can tailor our regulatory support to meet your unique needs.
Or to learn how our services can benefit your projects: