From Verification & Validation to Global Market Access | V&V, DHF & IMDRF

Developing a medical device successfully requires several pieces to work together. Manufacturers must demonstrate that the product meets its requirements, maintain reliable design documentation, and understand how regulatory expectations differ—or increasingly align—across global markets.

In this Easy Medical Device podcast collection, we explore three connected topics that represent different stages of this journey: Verification & Validation, Design History File remediation, and IMDRF and regulatory reliance.

Making Verification & Validation Practical

Verification and Validation are fundamental parts of medical device development, but the distinction between them can sometimes create confusion.

Verification focuses on whether the device has been developed according to defined requirements, while validation considers whether the resulting device meets its intended use and user needs.

Understanding how to plan and execute V&V effectively helps manufacturers build stronger evidence around device performance and supports a more structured development process.

When Your Design History File Needs Remediation

What happens when the product has already been developed, but the Design History File doesn't properly demonstrate the development journey?

DHF remediation can become necessary when documentation is incomplete, fragmented, poorly traceable, or does not adequately demonstrate how design controls were applied.

The discussion explores the importance of rebuilding those connections and creating documentation that clearly demonstrates the relationship between requirements, design activities, V&V evidence, risk management, and design decisions.

The objective isn't simply to create more documentation. It's to create a coherent and traceable design history.

IMDRF, Regulatory Reliance and Global Market Access