Medical Device Verification & Validation (V&V) Essentials

A professional, practice-oriented course that provides a clear and solid foundation for understanding, planning, and implementing Verification and Validation (V&V) activities as an integral part of medical device product development and the Quality Management System.

Dates: 9.11.26 + 12.11.26

Two-day online course   

Hours: 09:30–15:30

A combination of theory, examples, and professional discussion

Why This Course Matters

Verification and Validation (V&V) are not just technical test activities and not merely a regulatory checkbox.   They are the structured framework that connects what the product is intended to be, how it is designed, how risks are controlled, and how performance and safety are demonstrated.

In practice, many professionals working with V&V face challenges such as:

• Unclear distinctions between Verification, Validation, and Qualification

• Confusion between design validation and process validation

• Weak linkage between User Needs, Design Inputs, Risk Management, and testing

• V&V planning performed too late instead of being embedded in development

This course was designed to bring clarity, structure, and consistency to V&V activities.

Target Audience

• Medical device R&D engineers

• QA and RA professionals

• Verification and test engineers

• Anyone responsible for planning, executing, reviewing, or approving V&V activities

Prerequisites

• Basic understanding of medical device design and development and the product lifecycle

• Basic understanding of risk management concepts