Articles tagged with “design-history-file”

DHF Remediation: QMSR and Medical Device File Transition

Analyze FDA QMSR requirements for DHF remediation. Learn how to transition legacy Design History Files to the ISO 13485 Medical Device File framework.

40 min read

2/26/2026

fda qmsr dhf remediation medical device file iso 13485 design history file device master record 21 cfr part 820 regulatory compliance gap analysis