Verification vs. Validation Medical Devices

Verification and validation are essential elements of medical device development and quality management, ensuring that devices are designed correctly and perform as intended. Although often confused, verification and validation serve distinct purposes and are fundamental to demonstrating the safety, performance, and regulatory compliance of medical devices. A clear understanding of these concepts is critical for planning development activities, generating objective evidence and preparing technical documentation.

This training is specifically designed to provide medical device professionals with a practical understanding of verification and validation principles throughout the medical device lifecycle. Participants will learn how to distinguish between verification and validation activities, establish appropriate strategies and acceptance criteria and generate documentation that supports regulatory compliance under the EU MDR 2017/745.

Key Topics Covered:

• Principles and definitions of verification and validation
• Verification methods, including inspection, analysis, testing and demonstration
• Validation activities, including Revalidation, Monitoring and software validation
• Establishing acceptance criteria, traceability and objective evidence
• Documentation requirements and common deficiencies identified during audits and technical documentation reviews
• Practical examples, case studies and Q&A sessions

Benefits:

• Clearly distinguish between verification and validation and their respective roles
• Learn how to plan and execute effective verification and validation activities.
• Understand documentation and traceability requirements to support regulatory compliance.
• Improve the quality and consistency of verification and validation evidence throughout the product lifecycle.
• Reduce common deficiencies and strengthen readiness for audits and regulatory submissions.

Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH

Target Audience: Regulatory Affairs, Quality Assurance, Quality Management professionals, Professionals involved in product development, testing and regulatory compliance