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Broad Device Type Expertise
Class B to D In-Vitro Diagnostics, Companion Diagnostics (CDx), In-House Devices (LDTs)
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100+
Combined Years of IVD Consulting and Industry Experience
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95%
Team Members with a PhD (Genetics, Pharmacy, Molecular Biology)
Expert IVDR Services for Diagnostic Pioneers
Transitioning Legacy Devices to IVDR
Transitioning Legacy Devices to IVDR
Navigate existing IVD device transitions with comprehensive gap assessments, strategic reclassification analysis, and tailored action plans. We optimize your regulatory pathway while maximizing existing data utility through strategic intended use statement reshuffling.
Launching New Devices under IVDR
Launching New Devices under IVDR
Accelerate new IVD development with integrated market access, regulatory, and clinical strategies. We provide due diligence support, capability building for Technical Documentation and QMS, plus strategic Notified Body interactions from concept to CE marking.
Clinical Assays and CDx
Clinical Assays and CDx
Transform clinical assays into companion diagnostics with specialized CDx expertise. We align device development with medicinal product timelines, determine optimal clinical performance strategies, and navigate submission requirements across key EU markets.
In-House Devices (LDTs)
In-House Devices (LDTs)
Ensure Article 5.5 compliance with practical, risk-based approaches that strengthen existing QMS frameworks. We optimize Technical Documentation based on available lab data while seamlessly integrating IVDR requirements into operational workflows.
A Diverse Portfolio of 30 Blood Grouping Devices
Situation
A client faced the complex task of transitioning a diverse portfolio of 30 blood grouping devices from the In Vitro Diagnostic Directive (IVDD) to the stricter In Vitro Diagnostic Regulation (IVDR). The sheer number of devices presented a significant hurdle for achieving timely and efficient CE-marking.
Successes
Through our strategic intervention, the client successfully achieved CE-marking under IVDR for their entire portfolio of blood grouping devices, with a substantial reduction in the number of required conformity assessments (from 30 to 5), saving significant time, resources and accelerating market access.
Services by Veranex
Veranex developed a strategic approach focused on optimizing the conformity assessment process. Our team:
- Devised a sophisticated device grouping strategy: Identified and justified the grouping of the 30 individual devices into just 5 product families, a strategy that was subsequently approved by the Notified Body, significantly reducing the number of required conformity assessments.
- Provided comprehensive Technical Documentation (TD) support: Mitigation of existing technical documentation gaps, ensuring all files met IVDR requirements.
- Led performance evaluation activities: Expert writing of Performance Evaluation Plans (PEP) and Performance Evaluation Reports (PER).
- Managed analytical performance studies: Oversaw the design and execution of crucial analytical studies to gather necessary data.
- Optimized existing clinical data: Leveraged and optimized all available clinical data, including information from batch-to-batch release, to support the IVDR transition.
A Leading NGS Platform
Situation
A leading provider of a Next-Generation Sequencing (NGS) platform faced the critical need to transition their complex technology from the In Vitro Diagnostic Directive (IVDD) to the stringent requirements of the In Vitro Diagnostic Regulation (IVDR). This involved meticulous attention to detail given the innovative nature of NGS technology.
Successes
Through Veranex's strategic guidance and hands-on support, our client successfully achieved CE-marking for their NGS platform under IVDR. Our collaborative approach ensured that all regulatory hurdles were overcome, enabling the company to maintain market access and continue to provide their cutting-edge diagnostic technology.Services by Veranex
Veranex partnered with the client to strategically address the unique challenges of IVDR compliance for their NGS platform. Our expert team provided comprehensive support, including:
- Strategic Intended Use Optimization: Re-evaluated and restructured the device's intended use, enabling the client to effectively substantiate existing clinical evidence under the new IVDR.
- Meticulous Device Description Redefinition: Ensuring the description was clear, concise, and sufficiently comprehensive for Notified Body reviewers, facilitating a smoother assessment process.
- Expert Performance Evaluation Documentation: Authored the critical Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER), detailing the scientific validity, analytical performance, and clinical performance of the platform.
- Proactive Conformity Assessment Support: Provided continuous support throughout the conformity assessment process, including addressing and preparing responses to all Notified Body deficiencies.
FDA Medical Device Consulting
FDA Medical Device Consulting
Maximize global efficiency by pairing your IVDR strategy with streamlined FDA submissions. Our specialized team develops parallel evidence generation plans that satisfy both IVDR and FDA requirements, reducing redundant testing while accelerating simultaneous EU and US market entry for your diagnostics.
Quality Consulting
Quality Consulting
Build IVDR-ready quality systems that support your entire diagnostic portfolio. Our quality frameworks integrate the specialized batch verification, stability monitoring, and performance evaluation requirements unique to IVDR compliance while creating operational efficiencies across your organization.
EU Authorized Representative
EU Authorized Representative
Maintain continuous EU market access with our comprehensive Authorized Representative services. We manage all aspects of regulatory compliance and communication with authorities, providing the local presence manufacturers need under MDR and IVDR requirements.
IVD Clinical Studies
IVD Clinical Studies
Strengthen your IVDR performance evaluation with our specialized IVD clinical study expertise. We design and manage diagnostic clinical investigations that generate robust evidence for both scientific validity and clinical performance claims, transforming IVDR's stringent clinical evidence requirements into compelling demonstration of your diagnostic's real-world clinical utility.
