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.
What we offer
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)
Why Choose Future Diagnostics
25+ Years of Proven Validation Expertise
With two decades of hands-on experience, Future Diagnostics provides more than data — we
provide confidence. The benefits for you as a client include:
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.
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.
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:
– Real-time & accelerated stability
– Shipping stability
– In-use stability
What This 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:
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.
