Verification and validation

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. Biocult combines deep assay expertise, ISO 13485-aligned quality systems and CLSI-based protocols to produce the objective, regulator-grade evidence your product needs.

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Our verification and validation services

With more then two decades of hands-on, proven Validation experience, Biocult provides more than data, we provide confidence. Biocult 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)

Why choose Biocult

Accelerated time-to-market

We deliver submission-ready evidence quickly, helping you keep launch timelines on track.

Lower internal burden

Free your R&D and regulatory teams to focus on core innovation while we handle the complex study work.

Reduced risk of rejection or delay

Our robust, regulator-proof data ensures smooth interactions with notified bodies.

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 Biocult 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. This approach provides regulator-ready protocols and statistical analysis plans, reliable sample sourcing through our proven procurement network, seamless project management from protocol to final submission package, a shorter and safer path to CE marking, reduced operational stress for your team, and accelerated market entry with lower compliance risks.

IVDR validation

Since May 23, 2022, the IVDR (In Vitro Diagnostic Medical Devices Regulation) has replaced the IVDD, increasing regulatory requirements for diagnostic assays entering the EU market; to obtain and maintain CE marking, IVD manufacturers must demonstrate compliance across three key pillars, scientific validity, analytical performance, and clinical performance, while at Biocult we support you in navigating this complexity by providing robust, regulatory-grade analytical performance studies, enabling your teams to focus on innovation while we help ensure a clear and compliant path to IVDR conformity.

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