Design Dossier/DHF Updates - What to Keep

E

ElizSurg

#1
#1
Hello, I would really appreciate if someone could help me with the following query
My company is currently in the process of putting together procedures for Tech Files and Design History File. When a product is released, which should you keep as your live file (updating risk document, Essential Requirements, etc.) Can it be either one once you define where the updates are being made?
I would appreciate your guidance as I am new to this. The amount of documents that need to be created is comprehensive. I want to try and make the process as stream lined as possible for updating once a product is released.
Thanks for taking the time to read my post ...much appreciated :D
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
John Broomfield

John Broomfield

Staff member
Super Moderator
#2
#2
ElizSurg said:
Hello, I would really appreciate if someone could help me with the following query
My company is currently in the process of putting together procedures for Tech Files and Design History File. When a product is released, which should you keep as your live file (updating risk document, Essential Requirements, etc.) Can it be either one once you define where the updates are being made?
I would appreciate your guidance as I am new to this. The amount of documents that need to be created is comprehensive. I want to try and make the process as stream lined as possible for updating once a product is released.
Thanks for taking the time to read my post ...much appreciated :D
Click to expand...
ElizSurg,

The records generated by the design process and related processes:
  1. The product design plans (as kept up to date throughout the design)
  2. Design authorities and responsibilities
  3. Evidence of competence to fulfill authorities and responsibilities
  4. Design inputs (particularly the performance spec for the product under design)
  5. Design reviews (particularly issues and their resolution)
  6. FMEAs and other risk assessments
  7. Design validation plan and any changes
  8. Copies of verified design outputs
  9. Validation and revalidation results
  10. Copies of specs and drawings issued for purchasing and manufacturing
  11. Design changes including any repair or use as is disposition of NC product
  12. Copy of the user manual and any training manuals
That's about it!

John
 
Last edited:
M

Marcelo

Inactive Registered Visitor
#3
#3
The Technical file for CE marking is a mix of the Design History File and Device Master Record from the FDA. The technical file is also a summary of the device design documents, not all the documents themselves. Even the DHS can be thought as a list of separate documents (which is better to updating)

I now it?s not a very good answer, but in practice, you should update what needs updated. For example, if you update your risk assessment but the result is not a change to the way the device is manufactured (the DMR), you only need to update your risk assessment (and if you use the technical file and DHS as index, you do not need to update them in principle unless you control them by numbers and the numbers change).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Are DHR and Design Dossier synonymous? US Food and Drug Administration (FDA) 9
A What to expect in a Design Dossier Review for CE Marking by a Notified Body CE Marking (Conformité Européene) / CB Scheme 3
S Annex II List A - Notified Body Fees - Design dossier review and batch release EU Medical Device Regulations 2
B Required Knee Prosthesis Class III Tests and Design Dossier EU Medical Device Regulations 2
M MHRA (Medical & Healthcare Regulatory Agency) Design Dossier Review Delays EU Medical Device Regulations 2
L Time and Cost for a Notified Body to review a Design Dossier ISO 13485:2016 - Medical Device Quality Management Systems 7
B Suggestions on how to control a Design Dossier? Document Control Systems, Procedures, Forms and Templates 2
J What font do I use in a Design Dossier? EU Medical Device Regulations 5
R Design Dossier up to date required - Audit finding - CE Marking EU Medical Device Regulations 6
J What are the differences between a design dossier and a regular technical file? EU Medical Device Regulations 1
J Technical File vs. Design Dossier - Class II and Class III Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 12
K Review of Design Dossier Design and Development of Products and Processes 1
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 2
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
W Need for current design or process control FMEA and Control Plans 2
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Reliability Analysis - Predictions, Testing and Standards 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
L Design & Development of a SERVICE Service Industry Specific Topics 13
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A AS9102B - 3.6 Design Characteristics and form 3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design Input detail & specificity ISO 13485:2016 - Medical Device Quality Management Systems 4
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
D Design Transfer Template capturing Customer Specific Requirements Other Medical Device Related Standards 3
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
M Looking for a Presentation on Design for Excellence (DfX) Manufacturing and Related Processes 2
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
R Design and Manufacture Guidelines for Surface Mount Technology Misc. Quality Assurance and Business Systems Related Topics 9
optomist1 Design Exclusion, but now we might have an outsourced Product Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A Design process goal for ISO 9001 Manufacturing and Related Processes 23
Z Definitive definition of design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom