Clinical Quality Services

Struggling to establish or maintain your Clinical Quality Management System (QMS)? Whether you’re building a QMS from scratch, managing audits, or preparing for inspections, ensuring compliance is critical—but also challenging. That’s where we come in.

Our clinical team has auditors and QA experts who specialize in providing tailored support for all aspects of QMS, helping you meet your obligations (i.e. audits), and handling ad-hoc quality events (i.e. announced inspections).

What is clinical quality?

Clinical quality encompasses the systems, processes, and activities that ensure clinical research meets the highest ethical and regulatory standards. It involves:

Developing and maintaining Quality Management Systems
Conducting audits, managing findings, and implementing corrective and preventive actions (CAPA)
Preparing for audits and inspections and ensuring ongoing compliance

From establishing procedures to handling quality events, clinical quality is the backbone of ethical and compliant clinical operation.

Why is it important?

Why is clinical quality important?

Maintaining clinical quality is not just a regulatory obligation—it’s a fundamental part of clinical research.

For start-ups and growing companies, operational demands often overshadow the need for a QMS. However, a robust QMS is crucial for long-term success and compliance.
For established companies, independent audits and fresh perspectives ensure ongoing compliance and identify areas for improvement.
For all organizations, clinical quality safeguards the integrity of clinical research, protecting both participants and outcomes.

Discover how we can support

QMS development and maintenance

From building a QMS from scratch to updating existing systems.

Audit services

Internal audits, vendor audits, and pre-inspection visits to ensure compliance and readiness.

Inspection management

Guidance and support for announced or unannounced inspections.

Temporary quality support

Filling gaps in your team with experienced QA professionals when needed.

Why QbD Group?

Here’s why you can count on us:

Experience: a proven track record of supporting companies of all sizes, from start-ups to established organizations.
Tailored solutions: services designed to fit your unique needs, whether it’s a full QMS setup or ad-hoc support.
Independence: unbiased auditing and quality services that offer a fresh perspective.
Trusted partner: we prioritize your success by ensuring compliance, efficiency, and ethical standards.

Clinical Quality Services - Clinical - QbD Group (1)

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 Quality Services

What is clinical quality?

Why is clinical quality important?

How can we help?

QMS development and maintenance

Audit services

Inspection management

Temporary quality support

Why QbD Group?

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