Clinical Evidence Support
Demonstrating scientific validity and performance for IVDR
We provide expert support to streamline your clinical evidence strategy and medical writing needs, ensuring that your device meets regulatory expectations and reaches the market efficiently.
What is clinical evidence support?
Clinical evidence support is a service designed to help manufacturers create the clinical evidence needed for IVDR compliance. Your device’s performance must be clearly demonstrated through Scientific validity, Analytical performance, and Clinical performance.
We provide expert support to streamline your clinical evidence strategy and medical writing needs, ensuring that your device meets regulatory expectations and reaches the market efficiently.
Why is it important?
Over 40% of initial submission package deficiencies reported by Notified Bodies are related to clinical evidence.
IVDD to IVDR transition
Many devices previously certified under the IVDD are now subject to stricter IVDR requirements. Transitioning to IVDR may involve building new or revised clinical evidence documentation. This is crucial not just for regulatory approval, but also for ensuring the continued availability of devices that patients rely on.
New product development
Bringing a new IVD or CDx to market requires a solid clinical evidence strategy. From planning to reporting performance evaluations, this process is complex, time-consuming, and requires expert guidance. We can streamline this process for you, ensuring a quicker, compliant pathway to market.
Regulatory compliance
The clinical evidence needs to evaluate all aspects of the intended purpose of the device. Having the right strategy and a set of high-quality, pre-defined documents is essential for obtaining regulatory approvals and demonstrating product performance and safety.
Evidence-based decision-making
Regulatory and clinical evidence documents provide confirmation in supporting product claims. High-quality data and analyses influence regulatory decisions, labeling, and post-market surveillance.
Risk mitigation
Clinical evidence reduces the risks of adverse events and product recalls, helping to ensure the safety and quality of your device.
How can we help?
We know that demonstrating clinical evidence is a challenging process. Here's where we come in:
Clear strategy
Defining a strategy to support your IVD/CDx intended purpose.
Expert medical writing
Writing plans and reports ensuring documentation meets regulatory standards.
Compliance assurance
Evaluating existing documentation and providing a compliant way forward.
Ad hoc consulting
Flexible consulting services for external reviews or guidance.
Why choose QbD Group?
- Partner with our field experts to create a customized strategy for demonstrating clinical evidence.
- Receive an expert review of your clinical evidence documentation before submitting to the Notified Body.
- Save time by outsourcing the writing of clinical evidence documents to dedicated IVD medical writers.
为什么选择QbD Group
您值得信赖的合作伙伴
QbD IVD | Qarad experts combine years of strategy experience in Clinical Performance, Analytical Performance, and Scientific Validity with Notified Body recognition. With broad field expertise and a solution-driven approach, we deliver high-quality, IVDR-compliant documentation. Our tailored strategies focus on closing gaps, ensuring consistency and readiness for Notified Body review.
Many years of field experience.
Recognized by Notified Bodies.
Regulatory intelligence.
Tailor-made strategies.
FAQ
Frequently Asked Questions
