Clinical Evidence Support

Bringing your In Vitro Diagnostic Medical Device (IVD) or Companion Diagnostic Device (CDx) to market can be a complex, time-consuming process, especially under the strict requirements of the European IVD Regulation (IVDR). Demonstrating clinical evidence is a critical step to ensure that your product complies with regulatory standards.

If you're facing challenges finding your way through the maze of the IVDR or need assistance in compiling the necessary documentation, QbD Group is here to help.

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
Clinical performance

Whether you need guidance on your clinical evidence strategy, support with medical writing activities, an external review of your documentation, or a partner for your clinical performance studies, we can support you in every aspect of the clinical evidence process.

Discover why clinical evidence is essential

IVDD to IVDR transition for legacy devices

Many devices previously certified under the In Vitro Diagnostic Directive (IVDD) are now subject to stricter IVDR requirements. If your legacy device was self-certified under IVDD, the transition to IVDR may involve building new or revised clinical evidence documentation. This transition 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 for clinical evidence 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?

QbD_IVD_qarad-1

OVER 20 YEARS OF EXPERIENCE IN IVD

We know that demonstrating clinical evidence is a challenging process, especially with the high standards set by Notified Bodies.

Here's where we come in:

Clear strategy: we’ll help you define a strategy to support your IVD and/or companion diagnostics (CDx) intended purpose.
Expert medical writing: from writing performance evaluation plans and scientific validity documents to clinical performance reports, our team of expert medical writers will ensure your documentation meets regulatory standards and is ready for submission.
Compliance assurance: We evaluate your existing clinical evidence documentation and provide a pragmatic and compliant way forward.
Ad hoc consulting: our team offers flexible consulting services, whether you need an external review of existing documentation or guidance during your clinical evidence process.

Get in touch

Clinical Study Design Support - Clinical - QbD Group

Your partner in IVD expertise

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

Clinical Study Design Support - Clinical - QbD Group (4)

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.

Do we need to perform clinical performance studies?

Clinical performance can be demonstrated using one or a combination of the following:

Clinical performance studies (the preferred source)
Scientific, peer-reviewed literature
Published experience from routine diagnostic testing

QbD IVD | Qarad will assess your specific case to determine if your existing clinical performance data is sufficiently robust.

Our IVDD device was certified over 10 years ago. Does this make us automatically compliant for IVDR submission?

Unfortunately, no. The requirements under the IVD Regulation (IVDR) are significantly more extensive and stricter than those of the IVDD. One common challenge is creating an IVDR-compliant intended purpose, supported by strong clinical evidence to substantiate the claims. QbD IVD | Qarad can guide you in planning the necessary steps to transition your products from IVDD to IVDR compliance.

Resources

Webinar

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Whitepaper

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Whitepaper

The pathway from idea to patient under MDR

This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Discover all

Clinical Evidence Support

What is clinical evidence support?

Why is it important?

IVDD to IVDR transition for legacy devices

New product development

Regulatory compliance

Evidence-based decision-making

Risk mitigation

How can we help?

Your partner in IVD expertise

Many years of field experience

Recognized by Notified Bodies

Regulatory intelligence

Tailor-made strategies

Why choose QbD Group?

Do we need to perform clinical performance studies?

Our IVDD device was certified over 10 years ago. Does this make us automatically compliant for IVDR submission?

Get in touch

Resources

Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device

Clinical investigations under MDR: key insights and practical experiences

The pathway from idea to patient under MDR

CE Mark Renewal for bioXtra Products: A Success Story

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter