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.
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The post How to Remediate a Design History File (DHF) appeared first on Medical Device made Easy Podcast. hamza benafqir |
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