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IVDs  Our Industries - QbD Group

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.

 

Industry challenges

  • 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.

Industry challenges

  • 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.

We cover the full In Vitro Diagnostic life cycle

From regulatory expertise to quality assurance and clinical evidence, we partner with you to accelerate your journey from idea to patient.

IVD - Idea to patient - QbD IVD Qarad

Our services

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

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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.

Related offerings

Companion Diagnostics Services - QbD Group

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.

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

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Full lifecycle support

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Global presence

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Best managed company

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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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Connect with us at these events

Industry
Service

January

28.01 - 29.01

Clinical

OCT Medical Devices Europe 2025

Munich, Germany

February

02.02 - 06.02

Regulatory Affairs

Medlab Middle East 2025

Dubai, United Arab Emirates

March

11.03 - 12.03

Regulatory Affairs

RAPS Global Regulatory Strategy Conference 2025

Baltimore, Maryland, USA

May

13.05 - 16.05

Regulatory Affairs

RAPS Euro Convergence 2025

Brussels, Belgium
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Get the latest industry news

Staying on top of the latest in the life science industry can be a daunting task. This newsletter will keep you up-to-date with the latest news, blogs and webinars so you can keep ahead of the curve.
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Discover our expertise in other industries

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

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Pharma

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Medical Devices