DHF File - Shall the document cover all the variants?

A

Ashwini_U

#1
Hi, I want to prepare a DHF file for Class IIa product. This product has more than 70 variants (different specifications).

Currently, I am working on the System Requirements Document. Shall the document cover all the variants? or Do I need to segregate them?
Because during design verification & validation, I want to verify the requirements & user needs for all the variants.
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Ashwini_U,
You can document the specs in one system requirements or multiple separate files. I would be inclined to use one document because of paper maintenance and clarity towards external auditors. Your call..

-Shimon
 
Thread starter Similar threads Forum Replies Date
R Suggestions for putting together a DHF (Design History File) ISO 13485:2016 - Medical Device Quality Management Systems 3
S DHF File Change Control Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
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
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
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
M What are typical Roles & Responsibilities of DHF (Design History File) Librarian? US Food and Drug Administration (FDA) 6
N Control of Medical Device DHF (Device History File) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Paper based DHF (Design History File) updates for Software Updates 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
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
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
D Design controls - Inputs, outputs, V&V, DHF, DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
A FDA and NB audit of Engineering Drawings in DHF and DMR. Medical Device and FDA Regulations and Standards News 1
D DHF Responsibility after design handover Document Control Systems, Procedures, Forms and Templates 4
P DHF, DMR and DHR in MDR? EU Medical Device Regulations 6
S Our products borrow DHF documents from a previous DHF for another product ISO 13485:2016 - Medical Device Quality Management Systems 2
S Is an index necessary for DMR or DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Per IEC 62304, are DHF documents Configuration Items? IEC 62304 - Medical Device Software Life Cycle Processes 8
A Hundreds of Medical Devices & Accessories - 3 DHF's? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V What is required in terms of the DHR, DMR, DHF? Other Medical Device and Orthopedic Related Topics 4
O Distributors and ISO 13485 - DHF and DMR Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 7
E Design Dossier/DHF Updates - What to Keep EU Medical Device Regulations 2
D Incomplete DHF: Re-do or plug gaps? Design and Development of Products and Processes 6
K Retrospective DHF for an old non-registered device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J How to structure a DHF when all manufacturing is done by Contract Maufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D DHF Review - When does the FDA review the DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H Working from a previous design history. How can I best leverage the exisitng DHF? Other US Medical Device Regulations 4
W Update DHF (Device History Record) when DMR (Device Master Record) changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
V Medical Products: CE Marking - Are the DMR's, Technical Files, DHF, required? EU Medical Device Regulations 6
T DMR/DHF/DHR/Batch Records/Master Batch Records ISO 13485:2016 - Medical Device Quality Management Systems 3
M DMR, DHR and DHF physical form 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P What results of a design review are documented in a DHF? Design and Development of Products and Processes 9
K Technical file for mhra CE Marking (Conformité Européene) / CB Scheme 2
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom