Technical Documentation & Clinical Evidence
When it comes to regulatory requirements for in vitro diagnostics (IVDs), our team puts your needs first. With a deep understanding of industry standards, state-of-the-art practices, and the latest guidelines, we ensure your technical documentation and clinical evidence meet all current regulations. Our experts stay on top of the evolving regulatory landscape so you can focus on what you do best.
Navigating IVD regulations can be complex and time-consuming. Our experienced team provides an objective perspective, streamlining the technical documentation and clinical evidence creation and review process. We help expedite your compliance efforts, saving you valuable time and ensuring your documentation is thorough and timely.
Part of QbD Group
This service is supported by Qarad
Why QbD Group?
The new regulations for in vitro diagnostics introduce more stringent requirements for technical documentation and clinical evidence. With over two decades of experience, Qarad – a part of the QbD Group – offers unparalleled expertise. We handle your medical writing tasks and provide answers to your regulatory questions with precision and professionalism.
Our device compliance team works closely with you to identify your specific needs and deliver customized solutions. We provide advice and documentation that are not only compliant with the latest regulations but also tailored to your device, ensuring you meet all necessary standards with confidence.
Tailor-made IVD solutions
At QbD, we offer tailor-made IVD solutions designed to meet your specific compliance needs. Our dedicated team collaborates with you to develop a service plan that addresses your requirements efficiently and effectively, focusing on both technical documentation and clinical evidence.
Contact us
Don’t hesitate to reach out for expert assistance with your IVD device compliance needs. Our team of specialists is ready to help you navigate the complexities of regulatory requirements and ensure your success, particularly in the areas of technical documentation and clinical evidence.
