Verification and validation
We provide end-to-end Verification & Validation (V&V) services for in vitro diagnostics, supporting IVDR, FDA and other major markets. Our assay expertise, ISO 13485-aligned quality systems and CLSI-based protocols ensure objective, regulator-ready evidence for your product.
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.
Our services:
Across our verification, validation and performance evaluation services, we can provide:
- Sample sourcing and comparator procurement through established channels
- End-to-end project management, from protocol design through final report
- Study planning and protocol development
- Study execution and documentation
- Data analysis and reporting
Verification services
- Verification of design outputs against predefined requirements and acceptance criteria
- Analytical performance verification, where applicable
- Assay lot verification against design specifications
- Stability studies supporting shelf-life claims
- Traceable evidence linking outputs to design inputs
- Documentation supporting Design history file and regulatory submissions
Performance evaluation & validation services
- Analytical performance verification of the final assay according CLSI guidelines
- Clinical performance studies, where required
- Scientific validity studies, where applicable
- Stability studies supporting shelf-life claims
- Manufacture and release of validation lots
- Support for performance evaluation and clinical evidence generation
Start a Project
Let’s make something great together. Feel free to contact us for more information via the contact form.
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.
Verification, validation and performance evaluation in relation to the IVDR
Scientific validity, analytical performance and clinical performance studies may therefore contribute to the evidence generated during different stages of IVD development, verification and validation.
The classification and purpose of a particular study depend on factors such as the device, its intended purpose, the development stage, the requirements being assessed, applicable regulatory requirements and the claims being made.
The key distinction is therefore:
Verification demonstrates that the design meets predefined requirements. Validation demonstrates that the final device is suitable for its intended purpose. Performance evaluation under the IVDR provides the regulatory framework for demonstrating scientific validity, analytical performance and clinical performance in support of that intended purpose.
