6 professional templates to build your DMR & DHR documentation system. Aligned with FDA 21 CFR 820.181 and 820.184 requirements.
Medical device companies spend weeks creating documentation systems from scratch, only to discover gaps during FDA inspections. Missing or incomplete records lead to 483 observations, warning letters, and costly remediation.
FDA regulations describe what to include but not how to structure your documentation system.
DMR and DHR documents often exist in silos, creating traceability gaps that auditors flag.
Without standardized templates, every team member creates records differently.
6 ready-to-use templates that cover every aspect of DMR and DHR documentation required by FDA 21 CFR Part 820.
Comprehensive Device Master Record index covering device specifications, production processes, quality procedures, and labeling requirements.
Complete Device History Record template for tracking manufacturing dates, quantities, acceptance records, and release authorization.
Side-by-side comparison clarifying the differences, relationships, and regulatory requirements for DMR and DHR documentation.
Standardized template for capturing device specifications, materials, dimensions, and performance requirements.
Detailed production record template for documenting manufacturing steps, in-process checks, and operator sign-offs.
Pre-release verification checklist ensuring all DMR/DHR requirements are met before device distribution.
Every template maps directly to FDA 21 CFR 820 subsections so you can demonstrate compliance with confidence.
Skip the research and formatting. Start filling in your device-specific details immediately.
Built-in cross-references between DMR and DHR documents ensure end-to-end traceability.
Standardized formats mean every team member documents consistently, reducing review cycles.
One-time purchase. Instant download. Start building your compliance documentation system in minutes.
Secure payment via Stripe. Instant delivery to your email.