Technical Documentation & Clinical Evidence

Our team holds the specialized knowledge and experience in regulatory requirements for IVDs. They stay updated on industry standards, state-of-the-art, guidelines, and best practices, ensuring that your documentation complies with the latest regulations.

The team is well-versed in the IVD regulatory landscape, allowing them to work efficiently. They provide an objective viewpoint and can help expedite the process of document creation or review, saving your team time and ensuring that the documentation is reviewed or completed in a timely manner.

Device Compliance - Technical documentation & Clinical evidence - QbD

Part of QbD Group

This service is supported by Qarad

Why QbD Group?

OVER 20 YEARS OF EXPERIENCE IN IVD​

The new regulation on in vitro diagnostics includes new requirements for the technical documentation and clinical evidence of IVDs.

Preparing for the new IVD regulation is a time-consuming process for IVD manufacturers. Qarad – part of the QbD Group – can relieve you by performing medical writing tasks and answering questions with expert input.  

We have over 20 years of expertise with IVDs, ensuring advice and documentation that complies with the latest regulations and is tailored to your device.

Tailor-made IVD solutions

HOW CAN WE HELP YOU?

Our device compliance team offers tailor-made solutions. Together, we identify your needs and propose a service to address those needs.

Contact us

TALK TO AN EXPERT

Don’t hesitate to contact us if you have any need for IVD device compliance services. Our team of experts is happy to assist you!

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.