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In vitro diagnostics
Industry - In Vitro Diagnostics

In Vitro Diagnostics (IVD)

The in vitro diagnostics (IVD) industry is evolving rapidly, driven by technological innovations, complex regulatory landscapes, and the increasing need for global market access.

At Labmark, we help IVD manufacturers overcome these challenges with tailored solutions - from regulatory affairs and quality assurance to clinical evidence and technical documentation.

Partner with us to accelerate your journey from idea to patient.

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Offering comprehensive IVD services

We provide end-to-end support across the entire IVD lifecycle. Our services include:

IVD_IVDR Transition Support

IVDR transition support

We guide IVD manufacturers through the transition from IVDD to IVDR, ensuring compliance and efficiency.

  • Quality Assurance: gap assessments, QMS updates, mock audits, and IVDR-compliant process development.
  • Regulatory Affairs: strategic regulatory roadmaps, notified body selection, and submission support.
  • Technical Documentation: clinical evidence development, risk management, usability assessments, and IVDR-compliant technical files.

IVD_Companion Diagnostics (CDx) Support

Companion Diagnostics (CDx) support

Our expertise extends to supporting different stakeholders in the CDx ecosystem:

  • IVD Manufacturers: regulatory submissions, data management, project management.
  • Clinical Labs: site and supply management, quality assurance, legal representation.
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IVD_IVD CRO Services

IVD CRO services – Performance Evaluation Studies

We conduct clinical and usability studies that comply with:

  • IVD Regulation
  • Common Specifications
  • WHO Prequalification requirements
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We cover the full IVD 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

Why partner with Labmark?

YOUR IVD INDUSTRY EXPERT

 

With decades of expertise in IVD, we deliver solutions that drive success. Here’s why companies trust us:

  • Unmatched Regulatory Expertise – A team with extensive IVDR certification experience and strong relationships with notified bodies.

  • Proven Track Record – Over 100+ IVDR Technical Documentations completed since 2020.

  • Customized, High-Quality Solutions – Strategies tailored to reduce submission timelines by 25%-50%.

  • Global Reach & Industry Leadership – Supporting markets in global markets with over 50 employees and 500+ clients worldwide.

  • Full-Service CRO for IVD – With 10 years of experience, 250+ clinical performance studies conducted, and a reputation for compliance and quality excellence.

We help IVD manufacturers safely bring new devices to market, transition to IVDR, and generate the clinical evidence required for regulatory success.

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Experienced in the IVD field since 2010

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Full lifecycle support

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East Africa presence

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Best managed company