DHF Consulting and Remediation
We can produce and support all documentation required for your Design History File, per FDA part 820 and/or ISO 13485. We also perform consent decree remediation and product support.
DHF strategy
Project work plan development
Risk analysis, requirements, test protocols, testing and traceability
Provide DHF documentation
Consent decree remediation and product support
Design changes to mitigate non-compliance issues
Gap analysis, DHF and agency compliance and mitigations
60601-1 and 60601-2 gap analysis and remediation
Regulatory and non-compliance remediation
Case Studies
