Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes.

In this podcast episode, we provide a structured and practical discussion on:

The definition and purpose of a DHF

Key differences between FDA QMSR and ISO 13485 requirements

How the DHF concept is addressed within ISO 13485

When DHF remediation becomes unavoidable

Typical causes of remediation, including accumulated DHF debt

How to remediate a DHF without creating new compliance risks

Common pitfalls and practices to avoid

How to define a realistic and defensible remediation strategy

Regulatory communication considerations with:

National Competent Authorities

Notified Bodies

This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way.

If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach.

Links

Richie Christian Linkedin: https://www.linkedin.com/in/christianrichie/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice