III.B.5. Technical tender preparation: Definition of Verification and Validation procedures

Estimated Execution Time

1-2 weeks

Objective

To define the verification (compliance with requirements) and validation (fitness for intended use) framework to be included in the tender documentation, describing how compliance with requirements and fitness for use will be tested during the PCP/PPI phases. The framework clarifies what evidence suppliers will be expected to provide, under which conditions designs, prototypes, or solutions will be verified or validated, and how procurers will assess conformity, performance, and usability with their own equipment and tools.

Although not mandatory and not included in all PCP/PPI tenders, this activity is highly recommended to increase transparency, reduce ambiguity, and support fair and evidence-based assessment throughout the procurement lifecycle.

Who is Involved

Procurers / Contracting Authorities: define expectations, validate the verification and validation approach, and ensure procurement compliance.
Clinical Experts and End Users: contribute to validation scenarios and fitness-for-use criteria.
Technical Experts (IT, data, engineering, interoperability): define verification methods and technical evidence requirements.
Quality, Regulatory, or Risk Experts (where relevant): support alignment with applicable standards and regulatory constraints.
Project Department / Innovation Unit: coordinate the definition and consolidation of V&V procedures.
Supporting Entities / Knowledge Partners (consultants, test and validation specialists): support framework design and documentation.

Activities / Tasks

III.B.5.1. Define the verification. Concept for the tender

Describe, in general terms, how prototypes or solutions will be verified against the functional and technical requirements later in the process.
Define what types of evidence suppliers must provide (e.g., lab test results, compliance certificates, interface testing reports). Later it will depend on the technology and/or service solution the way the suppliers will provide it.
Include acceptance criteria examples and indicate how results will be documented (templates or structured reports).

III.B.5.2. Define the validation Concept for the tender

Describe the expected approach to validating usability, operational fit, and user satisfaction during the pilot or demonstration phase (e.g. pilot settings, real or near-real operational environments).
Specify which domains will be validated (e.g., performance, workflow integration, safety, interoperability).
Clarify that suppliers must propose validation plans consistent with their designs and compliant with ethical and regulatory rules.

III.B.5.3. Integrate verification and validation into the tender structure

Integrate the verification and validation in the tender structure, phases and milestones (how and where):
- Technical specifications (what will be verified/validated).
- Evaluation criteria (how verification readiness will be scored).
- Contractual annexes (how results will be later confirmed).
Ensure the verification and validation framework is coherent with PCP phases (Phase 2 = Verification, Phase 3 = Validation).
Include verification and validation framework in the initial phase (change management phase) of a PPI.
Define how verification and validation results will inform go/no-go decisions between phases.
Verify alignment between requirements, evaluation framework, and verification and validation framework and expectations. Consolidate them, include and clearly state them in the tender.
Ensure clarity for suppliers on expectations, evidence requirements, and assessment methods.
Confirm that the proposed procedures are realistic, non-discriminatory, and allow suppliers room for innovation.

Tips / Common Pitfalls

✅ Keep V&V requirements proportionate to project scope and maturity level.

✅ Clearly distinguish verification from validation in tender documentation.

✅ Use V&V to reduce ambiguity and misalignment with suppliers early on.

❌ Avoid imposing full certification or regulatory validation requirements within PCP phases.

❌ Do not define V&V procedures that are unrealistic within project timelines or budgets.

❌ Avoid excessive technical detail that could constrain innovation.

Outcome / Deliverables

Verification and Validation framework suitable for inclusion in tender documentation.
Clear description of evidence requirements and testing conditions for suppliers.

Resources

Regulatory Resource Repository Process validation in medical devices

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