This document summarizes key aspects of medical device design history files (DHF), including what they are, their contents and purpose. It explains that a DHF is a compilation of records documenting a device's design history, as required by quality standards. It must include inputs, outputs, risks analyses, verification and validation reports from the design process. The DHF feeds into the device master record and provides a history of how a device's design was developed and tested according to approved plans and regulations.

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2. Overview
• The DHF in depth
• DSD Management
• Verification Protocol & Report
• Validation Protocol & Report
Sample from “Advanced Medical Device Development”
http://medicaldevicecourses.com/2015/03/advanced-medical-device-development/

3. Design History File
• 820.3(e) – “a compilation of records which describes the design
history of a device”
• Established/maintained for each type of device
• Demonstrates that design was developed per approved plans and
QSR requirements
• Not actually a requirement in ISO 13485 or 9001

4. Design History File
DHF plus DMR
• Shows history of design
• Shows Input = Output
• Logs all Design Control elements
and where to find them (DMR)
• Shows all development leading
up to release, and after Transfer
• Fulfills 21 CFR 820.30
Tech File / Design Dossier
• Shows snap shot of design
• Not designed as an index or log
of all documents
• Shows a product at time of
release (after Transfer)
• Proves adherence to Essential
Requirements

5. Design History File
• Design History File (DHF)
Inputs to
• Device Master Record (DMR)
Inputs to
• Device History Record (DHR)

6. Design History File
• Every step of Design Control creates info to be recorded
• DHF = compilation of all this info
• No requirement on DHF location or organization
• Some designers assemble/maintain entire DHF
• Some leave this to Document Control dept.

7. Design History File
• Contents
• Project proposal
• DDP – all tasks, lists of deliverables
• DID, DSD
• All documentation of Design Outputs
• Results of V&V – Protocols, Reports
• Documentation of Design Reviews
• References to controlled documents

8. Design History File
• Design Transfer information
• Plus –
• Meeting minute notes
• Basic research used to start Design Controls
• Risk Analysis Documents
• Change control documents
• Process Validation data

9. Design History File
• Design Development Plan
• Lists team members
• Has start date for project
• Gives statement of purpose
• Gives schedule with changes (living document)
• Gives basic rules for project flow

10. Design History File
• Design Input Document
• Lists basic specifications (non-detailed)
• Lists standards that must be followed
• Gives basic idea of packaging
• Declares which quality standards will be followed

11. Design History File
• Design Specification Document
• Project from MDD went up to this point but did not include it
• See example

12. Design History File
Design Specification Document
• Can function as a Design Matrix
• Or a separate document can have the Design Matrix
• Design Matrix tracks entire process of design
• Living document
• Every DID line gets at least one line in DSD
• Every DSD line gets at least one Verification Protocol test or rationale
for why not tested

13. Design History File
Design Specification Document
• Linkage with Risk Management
• RA may show need for mitigation or design alteration
• DSD adds a line to address this
• References the risk that is listed in the RA or DFMEA

14. Design History File
DSD # INPUT # INPUT REQUIREMENT RISK ANALYSIS OUTPUT VERIFICATION VALIDATION
Design Matrix
Is often part of the DSD, or can be separate

15. Design History File
DSD # INPUT # INPUT REQUIREMENT RISK ANALYSIS OUTPUT VERIFICATION VALIDATION
Design Matrix
DSD# and INPUT#
DSD Line numbers – listed sequentially for DSD#
Input number copied from DID
DSD line numbers can be hierarchical
Once a line number is used in a release doc, cannot be reused

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