Clinical Strategy Support

Defining the complex world of clinical strategy for your (software as a) medical device can feel overwhelming.

Whether you're a manufacturer of Class I to Class III medical devices of a start-up or an established multinational, the stakes are high: ensuring regulatory compliance, optimizing clinical evidence, and achieving market approval.

We are here to simplify this process for you, providing the expertise and guidance you need to define a robust clinical roadmap tailored to your unique challenges.

What is clinical strategy support?

Clinical strategy support involves creating a clear and comprehensive plan to determine the quantity and quality of clinical evidence required for your medical device, both pre-market and post-market.

The European Medical Device Regulation (EU MDR) lacks detailed guidelines on what constitutes sufficient clinical evidence, leaving many manufacturers uncertain about their next steps.

This is where QbD Group steps in. Our multidisciplinary team of experts—including physicians, regulatory specialists, clinical experts, quality professionals, and statisticians—collaborates to design a clinical strategy that meets all regulatory expectations while aligning with your business objectives.

Discover how we can help

Market approval

Without sufficient clinical evidence, gaining market approval can be a costly and time-consuming hurdle.

Resource efficiency

A targeted approach ensures you allocate resources effectively, saving time and money.

Market success

By addressing regulatory and clinical requirements early, you set your product up for smoother market entry and sustained success.

How can we help?

We’re equipped to guide manufacturers like you of Class I to Class III medical devices through every step of your clinical strategy.

Here’s how we support you:

Tailored guidance: We provide expertise on generating clinical data and clinical evidence tailored to your device’s needs.
Regulatory compliance: We ensure your strategy aligns with EU MDR and other regulatory frameworks, facilitating a smoother path to market approval.
Efficiency: We help streamline what is often a resource-intensive process, saving you time and effort.

Here's what you can expect:

Ad hoc consultancy: Flexible, expert advice when you need it.
Therapeutic-specific advisory boards: Establishment of medical and scientific advisory boards tailored to your therapeutic area.

Get in touch

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Resources

Case study

Fast-Tracked Site Qualification for Clinical Trial Submission

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.

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 Strategy Support

What is clinical strategy support?

Why is clinical strategy support important?

Market approval

Market approval

Resource efficiency

Resource efficiency

Market success

Market success

How can we help?

Get in touch

Resources

Fast-Tracked Site Qualification for Clinical Trial Submission

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