Verification & Validation Strategy Advisory - Free (No Form of Payment Required)

Designed for medical device manufacturers and SaMD development teams who need clarity on their V&V strategy, whether you are building a validation framework for the first time, closing gaps ahead of a submission, or untangling a V&V approach that has grown inconsistent over time.

This complimentary consultation is a structured 45-minute conversation with an experienced medical device regulatory consultant. No sales pitch. Just a focused, expert discussion about your product, your current V&V posture, and the most defensible path forward.

What We Cover

Depending on your situation and priorities, the conversation will focus on the areas most relevant to your current stage. This may include:

• Your overall verification and validation strategy and master plan structure
• Unit, integration, system, and user acceptance testing coverage
• Traceability between design requirements, risk controls, and test evidence
• Alignment between verification activities and ISO 14971 risk management outputs
• Software validation considerations under IEC 62304 if applicable
• Documentation quality and test evidence readiness for regulatory review
• Identification of gaps that could lead to submission deficiencies or audit observations.

What You Walk Away With

A clear assessment of where your V&V strategy stands today, identification of the gaps most likely to draw FDA or notified body scrutiny, and a straightforward recommendation on whether a productized documentation system, a targeted consulting engagement, or a combination of both is the right next step for your organization.

Who This Is For

This consultation is built for development and quality teams at any stage, whether you are mapping out a V&V strategy from scratch, preparing V&V documentation for a 510(k) or De Novo submission, responding to a deficiency or audit observation related to testing coverage, or stress-testing an existing V&V framework before your next regulatory interaction. If your V&V documentation feels fragile, incomplete, or disconnected from your risk management activities, this call will give you a clear picture of what needs to change and why.

How It Works

We will contact you to select a time that works for you. You will receive a brief preparation guide to help focus the conversation on your specific product, development stage, and regulatory context. No formal preparation required beyond that.

What This Is Not

This consultation is not a substitute for a full V&V audit, test execution support, regulatory strategy engagement, or submission support. If your needs extend beyond an advisory conversation, please contact us so that we may find you a better fit.

Typical Outcomes From This Call

Every situation is different, but most teams leave this call with one of the following outcomes:

Outcome 1: V&V Plan Alignment

Your verification and validation approach is largely sound. We identify specific improvements to strengthen traceability, test coverage, or documentation clarity to ensure your V&V framework aligns with regulatory expectations.

Outcome 2: Targeted Test Strategy Gaps

We identify gaps in your testing structure — commonly involving incomplete traceability, unclear test coverage across unit/integration/system levels, or weak linkage between risk management outputs and validation activities. We outline a prioritized path to strengthen the testing framework.

Outcome 3: V&V Framework Requires Structural Development

Your testing activities may exist but lack an integrated strategy connecting requirements, risk management, and validation evidence. In these cases we typically recommend establishing a structured V&V framework to ensure your testing approach is defensible during regulatory review.