In Vitro Diagnostics

The in vitro diagnostics (IVD) landscape is evolving rapidly, propelled by technological innovations, stringent regulatory requirements, and the growing demand for seamless access to global markets.

At QbD Group, we are dedicated to offering customized services for IVD manufacturers to adeptly address these challenges. From regulatory expertise to quality assurance and clinical evidence, we partner with you to accelerate your journey from idea to patient.

Implementation of IVDR: Adjusting to increased regulatory scrutiny, limited availability of notified bodies, managing new classification systems, and more stringent clinical evidence requirements.
Market access delays: Ensuring seamless product launch timelines amidst evolving regulations.
Companion Diagnostics: Addressing the growing need for precise and effective companion diagnostic tools.

Balancing innovation and regulation: Harmonizing cutting-edge developments such as AI, Medical Device Software (MDSW), and Companion Diagnostics with compliance requirements.

Digital Health and Data Integration: Adapting to advancements like AI-driven diagnostics, MDSW lifecycle management, and secure data integration.

Our services

QbD Group offers a comprehensive suite of services tailored to address the unique needs of IVD manufacturers.

Quality Assurance

Implementation of FDA, EMA, FAHMP, and ISO standards (ISO13485, ISO14971, etc.)
Internal and external audits by certified lead auditors.
Lifecycle management for Medical Device Software and digital health solutions.

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Clinical Services

Strategy and protocol development for clinical evidence generation.
Site selection, monitoring, and regulatory support.
Comprehensive medical writing, incl. scientific validity reports and post-market performance follow-up documentation.

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Regulatory Affairs

CE Marking, FDA clearance, and market entry strategies.
Technical documentation and submission packages for IVDR and global markets.
PRRC services, in-country representation, legal representation, and post-market regulatory support.

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Related offerings

Companion diagnostics services

Whether you’re struggling with co-development complexities, regulatory compliance, or market access strategies, our dedicated teams of regulatory experts are here to support you.

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Why partner with QbD Group?

YOUR IVD INDUSTRY EXPERT

Unmatched IVD expertise:

A team of regulatory professionals well-versed in the IVDR certification process.
Experienced medical writers and clinical evidence experts.

Industry-leading experience

Over 100 IVDR Technical Documentations completed since 2018.
Recognized by Notified Bodies for our quality and compliance standards.

Tailored, High-Quality Solutions

Customized strategies for your unique transition from IVDD to IVDR.
Proven methods to reduce submission timelines by 25%-50%.

Pragmatic and Systematic Approach

Comprehensive project coordination across stakeholders.
A commitment to precision, compliance, and efficiency in every deliverable.

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10+ years of experience

Full lifecycle support

Global presence

Best managed company

Get in touch

Work with QbD Group to ensure your in vitro diagnostic products meet regulatory requirements and reach the market efficiently. Fill out the form and our experts will guide you through every step of the process.

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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.

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Discover our expertise in other industries

In addition to In Vitro Diagnostics, QbD Group supports innovation and compliance in Pharma & Biotech and Medical Devices. Discover how our tailored solutions help drive success in these specialized fields.

In Vitro Diagnostics

Industry challenges

Industry challenges

We cover the full In Vitro Diagnostic life cycle

Our services

Quality Assurance

Clinical Services

Regulatory Affairs

Related offerings

Companion diagnostics services

Why partner with QbD Group?

10+ years of experience

Full lifecycle support

Global presence

Best managed company

Get in touch

Related expert content

IVDR extension: what does this mean for you?

Mobile health on the rise: exploring the regulatory landscape for reimbursement

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Mastering Clinical Performance Studies under IVDR

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

When does Annex XIV apply in Performance Studies, and what key documentation is needed for compliance?

How to define your Clinical Performance Strategy?

The Holy Grail: Achieving Inspection Readiness

Connect with us at these events

February

03.02 - 06.02

Medlab Middle East 2025

11.02 - 02.12

BIVDA 2025 Regulatory Affairs Summit

24.02 - 25.02

RMD Annual EAAR conference on new MDR

27.02 - 28.02

International Conference on Stem Cells & Regenerative Medicine

March

01.03 - 02.03

International Conference on Gene & Cell Therapies

11.03 - 12.03

RAPS Global Regulatory Strategy Conference 2025

18.03 - 19.03

Advanced Therapies Congress

22.03 - 24.03

CALCP

25.03 - 29.03

IDS 2025

April

08.04 - 10.04

World Clinical Biomarker & CDx Europe Summit

11.04 - 15.04

ESCMID

30.04 - 01.05

AMDM Annual Regulatory Meeting

May

08.05 - 08.05

Knowledge for Growth

08.05 - 09.05

EMWA Symposium

12.05 - 14.05

ISPE Europe Annual Conference

13.05 - 16.05

RAPS Euro Convergence 2025

13.05 - 16.05

Raps EuroConvergence 2025

20.05 - 23.05

EuroPCR: World-Leading Course in interventional cardiovascular medicine

22.05 - 22.05

Symposium on Diagnostic and surveillance of infectious diseases (Sciensano)

June

03.06 - 04.06

OCT Medical Devices USA

11.06 - 13.06

EFORT Annual Congress

16.06 - 19.06

Bio-International

24.06 - 26.06

CPHI China

26.06 - 27.06

PDA Advanced Therapy Medicinal Products Conference (Europe)

September