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Verification & Validation Services
We provide end-to-end Verification & Validation (V&V) services for in vitro diagnostics intended for the EU (IVDR) and other major markets including the USA (FDA). Verification & Validation are essential phases of your Design History File and technical documentation—critical for CE marking, FDA registration and smooth regulatory inspections. Future Diagnostics combines deep assay expertise, ISO 13485-aligned quality systems and CLSI-based protocols to produce the objective, regulator-grade evidence your product needs.
Our verification and validation services
With more then two decades of hands-on, proven Validation experience, Future Diagnostics provides more than data — we provide confidence. Future Diagnostics combines deep assay expertise, ISO 13485-aligned quality systems and CLSI-based protocols to produce the objective, regulator-grade evidence your product needs.
Verification services
- Benchmarked verification lots against design requirements
- Objective evidence demonstrating the product meets specifications
- Accelerated stability studies for indicative shelf life
Validation services
- Analytical performance studies and (accelerated) stability studies of the final assay.
- Manufacture validation lots, QC release and labelling as Investigational Use Only (IUO) for analytical/clinical validation.
- Validation performed according to CLSI guidelines and documented in ISO 13485-compliant reports.
- Sample sourcing and comparator procurement through established channels
- End-to-end project management (from protocol design through final report)
Your highly skilled experts
From plate-based assays to point-of-care devices and high-throughput clinical analyzers, we support all IVD platforms with state-of-the-art labs and a highly skilled V&V team fluent in both IVDR requirements and instrument-specific best practices. Contact us for more information.
Why Choose Future Diagnostics
Accelerated time-to-market
We deliver submission-ready evidence quickly, helping you keep launch timelines on track.
Reduced risk of rejection or delay
Our robust, regulator-proof data ensures smooth interactions with notified bodies.
Lower internal burden
Free your R&D and regulatory teams to focus on core innovation while we handle the complex study work.
Greater certainty and peace of mind
With our experts as your partner, you avoid costly rework and regulatory surprises.
Complete analytical performance studies – Seamless End-to-End Support
Our clients choose us because we deliver everything needed for Annex I Section 9.1a compliance in one complete, regulator-ready package:
- Detection capability (Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ))
- Specificity testing (interference & cross-reactivity)
- Trueness/accuracy
- Method comparison
- High-dose hook
- Matrix equivalence
- Precision studies (repeatability & reproducibility)
- Linearity and measurement range determination
- Stability studies
- Real-time & accelerated stability
- Shipping stability
- In-use stability
- Detection capability (Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ))
- Specificity testing (interference & cross-reactivity)
- Trueness/accuracy
What our Verification and Validation services Means for You
Outsourcing your Verification & Validation (V&V) to Future Diagnostics means leveraging our deep expertise and accredited processes to navigate complex regulatory landscapes. We ensure your product not only meets stringent requirements but also gains a competitive edge, allowing your team to focus on innovation while we handle the critical steps for compliance and market readiness. Outsourcing will offer you the following benefits:
- Regulatorready protocols and statistical analysis plans
- Reliable sample sourcing through our proven procurement network
- Seamless project management from protocol to final submission package A shorter, safer path to CE marking
- Reduced operational stress for your team
- Accelerated market entry with reduced compliance risks
IVDR Validation
Since May 23, 2022, the IVDR (In Vitro Diagnostic Medical Devices Regulation) replaced the IVDD, raising the bar for diagnostic assays entering the EU market. To achieve and maintain CE marking, IVD manufacturers must demonstrate compliance across three critical pillars: scientific validity, analytical performance, and clinical performance.
At Future Diagnostics, we help you cut through this complexity. Our analytical performance studies deliver the robust, regulatory-grade evidence you need — so your teams can focus on innovation, while we safeguard your path to IVDR compliance.
Contact us
Contact Future Diagnostics today to discover how our verification, validation, and analytical performance services can help you gain speed, efficiency, and confidence on your route to CE marking.