Analytical and clinical performance studies for diagnostics developers

Analytical services help medical device and in vitro diagnostic (IVD) manufacturers generate the data required to support product development, performance evaluation, verification, validation, technical documentation and regulatory submissions. Analytical testing plays an important role in demonstrating product performance, supporting quality management activities and building the evidence required for market access across the UK, EU and US. Our analytical services are designed to integrate with wider regulatory, quality and clinical strategies to support successful product commercialisation.

ISO/IEC 17025 is the internationally recognised standard for testing and calibration laboratories. Working with an ISO/IEC 17025 accredited laboratory demonstrates that testing activities are performed using validated methods, competent personnel and robust quality processes. For medical device, diagnostics and healthcare technology companies, ISO/IEC 17025 accreditation provides confidence in the reliability, traceability and integrity of analytical data used to support product development, performance claims and regulatory submissions.

Analytical testing provides objective evidence to support regulatory submissions and technical documentation. Whether preparing for FDA submissions, EU MDR compliance or IVDR compliance, manufacturers must demonstrate product performance, safety and effectiveness using robust supporting data. Analytical evidence may contribute to verification activities, validation programmes, risk management documentation, clinical and performance evaluations, and overall regulatory readiness.

Analytical testing should be considered as early as possible during product development. Early analytical planning helps manufacturers define evidence requirements, reduce development risk, support regulatory strategy and avoid delays later in the development process. Incorporating analytical activities during the design and development phase can strengthen verification and validation programmes while supporting a more efficient route to market.

Yes. Analytical services can support organisations developing AI-enabled medical devices, Software as a Medical Device (SaMD), digital health platforms, connected healthcare technologies and AI-powered diagnostic solutions. Analytical evidence may be used alongside regulatory strategy, technical documentation, risk management and performance evaluation activities to support market access and regulatory compliance. Our teams work with developers to establish appropriate evidence generation strategies for innovative healthcare technologies.

Analytical testing generates evidence that can support technical documentation, quality management systems, regulatory compliance activities and market access programmes. Robust analytical data helps manufacturers substantiate performance claims, support risk management processes and demonstrate compliance with applicable regulatory requirements. Integrating analytical activities with regulatory, quality and clinical programmes creates a stronger foundation for successful submissions and long-term compliance.