Design History File - Looking for Examples of DHF's.

K

KatrinW

Registered
#1
#1
Dear Forum,

I am studying clinical research management in my 5th semester. For my current term paper I am looking for design history files. I can't find an example anywhere to get an idea of this document. In this forum I have already read that it can be between 100 and 10000 pages. I also realize that no one will give me their original DHF. But is there somewhere the possibility to find examples at least for some sections?

For my term paper I need especially the verification, the design review and design changes. Theoretically I know from the FDA guidelines what belongs there, but it is hard to write about it without ever having seen a DHF.

Please help me.
Best regards Katrin
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Y

yodon

Leader
Super Moderator
#5
#5
Do realize the DHF is more of a virtual file. It's the collection of all design history documents. Some of the things in the checklist in the thread @Jim Wynne directed you to aren't necessary for the DHF (e.g., kickoff meeting minutes, business analysis, etc.). 21 CFR 820 provides the framework for the DHF but there's a lot once you start peeling the onion. For example, the checklist shows a "Hazard Analysis" but risk analysis is (generally) driven by ISO 14971 and our normal set of risk analysis docs includes a Risk Management Plan, a System Hazard Analysis, Design FMEA, Use FMEA, a Software FMEA (if product includes software), and a Risk Management Report.

As you probably know, verification is confirmation that the design outputs meet the design inputs. Another way to think of it is "did we build the thing right" (contrast with validation, "did we build the right thing"). You'll have test protocols that drive the means to collect objective evidence that the requirements are satisfied. The executed protocols are records that identify who tested, when testing was done, what equipment was used, how many samples (statistically justified), etc. There's generally a test report summarizing testing and providing rationale for any issues found that are not to be corrected. The collection of design verification materials can often be well into the hundreds of pages, depending on complexity of the product (and the efficiency of the test developers!).

Design reviews are more formal reviews (not to be confused with a review of a particular document). The number of design reviews is established in the design and development plan. Generally, the only outputs are the minutes (listing the items reviewed and participants) and any action items arising.

Design changes authorize changes after you put something under design controls. These are just records that effectively authorize the change. There are particular requirements for assessing impact, e.g., to risk, to products in the field, to items in work, etc.
 
K

KatrinW

Registered
#6
#6
Thank you for your detailed reply and effort. I am quite enthusiastic about this platform. I had doubts before that anyone would even take the time to read my post. Thank you.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Audit Finding - Design History File (DHF) Index: few (3 to 4) reports not identified ISO 13485:2016 - Medical Device Quality Management Systems 3
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
R No design history file or device master record ISO 13485:2016 - Medical Device Quality Management Systems 5
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 3
D Questions about the contents of a Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Template / format for Device History File & Design Verification of transdermal patch 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
JoCam Ownership of Design History File EU Medical Device Regulations 6
K ISO 13485 and DHF (Design History File) requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
M Design History File (DHF) for New Generation of Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N 510k without DHF (Design History File) that we bought a 3 years ago US Food and Drug Administration (FDA) 4
A DHF (Design History File) for a Legacy Product (Class iii Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B When To Share Your DHF (Design History File) With A Customer US Food and Drug Administration (FDA) 1
S Cost Targets as Design Inputs in your DHF (Design History File) US Food and Drug Administration (FDA) 7
C Should Research Findings be in the Design History File? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
renenatasha Usage of web articles in DHF (Design History File) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A Medical Device DHF (Design History File) - One per Design Change? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
L Creating DHF (Design History File) for Medical Device Systems Design and Development of Products and Processes 8
O ISO Standards For Intramedullary Pin Design History File Other Medical Device Related Standards 2
K How to start a Design History File (DHF) for Medical devices Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Design History File DHF Practices and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design History File (DHF) - Buy-For-Resell Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
A Design History File Maintenance - Who is responsible for the Design History File 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M What are typical Roles & Responsibilities of DHF (Design History File) Librarian? US Food and Drug Administration (FDA) 6
H Paper based DHF (Design History File) updates for Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Who should document the Design Review Meeting and Design History File? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Q DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 50
C Remediating a Design History File (DHF) for an IVD developed prior to 1997 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Design History File (DHF) Maintenance Information wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
O DHF (Design History File) Template Other US Medical Device Regulations 13
C How to establish a Design History file (DHF)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
W Design History File (DHF) Template Example for Consideration. Design and Development of Products and Processes 12
S Which documents in the DHF (Design History File) should be controlled? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q DHF (Design History File) on New Medical Device Product ISO 13485:2016 - Medical Device Quality Management Systems 9
M Design History File - Medical Device Quality Systems Manual Section 3, Design Control Design and Development of Products and Processes 1
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
N Design Validation Conventions for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
B Design history files for combination products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Maintaining Component Traceability in DHR (Design History Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Medical Device Service Records linked to DHR (Design History Record)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Better control of DHR (Design History Record) during processing Document Control Systems, Procedures, Forms and Templates 5
R Cloud Computing Requirements for Design History Files for Software Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M DHR (Design History Record) Requirements - Concessions Quality Manager and Management Related Issues 12
W Design History Verification Records Control and Approvals US Food and Drug Administration (FDA) 3
A Is a Distributor responsible for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
H Working from a previous design history. How can I best leverage the exisitng DHF? Other US Medical Device Regulations 4
M Risk-based approach to Test Method Validation for Design Verification? US Medical Device Regulations 4
S Is design and development clause 8.3 applicable for laboratory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Design: Verification Vs Validation And Validation Vs Transfer ISO 13485:2016 - Medical Device Quality Management Systems 19
L To control the essential design outputs Medical Device and FDA Regulations and Standards News 4

Similar threads

Top Bottom