Design Verification & Design Outputs - FDA and 13485

M

MIREGMGR

#11
#11
patmelad said:
We were written up for excluding design and development. We outsource all design function but we do own the product and also have all of the design records which we maintain.
Click to expand...
The regulatory point is that, while you contract with someone else to practically perform design and development, you remain regulatorily responsible for those functions. Therefore your QMS must include procedures, and your operational records must provide evidence of implementation of those procedures, in regard to how you effectively control all of the regulated aspects of the performance and outcome of design and development work done by your supplier.
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
R

rlbate

#12
#12
I think the point to be taken is you, as the design owner, are required to control the design function and subsequent process. Your organization should have procedures in place regarding how the relationship between you and your design supplier works, who is responsible for what, including the format of what ever it is you are calling your design records. Since you don't state who wrote you up I will assume it was a notifying body (your registrar). Your registrar is telling you that you cannot exclude procedures for the design and development process. I'm sure they would want to see how you control planning - your procedure might say "our company requires the subcontractor to provide a plan for building "X" product and is signed and approved by our company regulatory and engineering heads", and your input procedure (if you choose to seperate requirements) might say these are the minimum inputs required and need to be approved by our company Marketing team. How is the validation protocol agreed upon and approved? You can go through the same process with each of the other design and development elements.

Hope this helps.
 
P

patmelad

Starting to get Involved
#13
#13
rlbate said:
I think the point to be taken is you, as the design owner, are required to control the design function and subsequent process. Your organization should have procedures in place regarding how the relationship between you and your design supplier works, who is responsible for what, including the format of what ever it is you are calling your design records. Since you don't state who wrote you up I will assume it was a notifying body (your registrar). Your registrar is telling you that you cannot exclude procedures for the design and development process. I'm sure they would want to see how you control planning - your procedure might say "our company requires the subcontractor to provide a plan for building "X" product and is signed and approved by our company regulatory and engineering heads", and your input procedure (if you choose to seperate requirements) might say these are the minimum inputs required and need to be approved by our company Marketing team. How is the validation protocol agreed upon and approved? You can go through the same process with each of the other design and development elements.

Hope this helps.
Click to expand...
Yes it was the registrar that wrote us up for this. Our comany used to have a design /eng department. We no longer have that but we do have the existing drawings and the original equipment. We needed to have some changes done for 60601-1-2 requirements. Any design work would be to an existing product not for any new products. I was looking through some of the forms online here and I found what was called a Design control worksheet which covered Planning , inputs, outputs,review, verification and validation. As well as a summary of design control activities which was geared more towards the RISK Analysis of the final product after changes, The records them selves I could cover under document control and maybe some kind of agreement to be signed by the design company covered under purchasing?. I am somewhat new and trial by fire seems to be the best description. Thank you for the reply any other thoughts would be greatly appreciated
 
R

rlbate

#14
#14
For changes in accordance with IEC 60601-1-2 or any other changes you should have a procedure that describes how you would handle changes to the design - this could/should be handles through your engineering change control procedure. The change procedure would require details of the change as well as who is approving (in your company) the changes.

I wouldn't get too caught up in trying to make a complicated system. Since you contract out the design process, your organization could have one procedure that addresses each of the elements of 7.3 Design and development:

7.3.1 Design and development planning - Could simply state, a plan will be created and approved by "X". The plan shall consist of "put any components you want here such as: input reviews, testing, validation, design reviews, and other misc. reviews as necessary."

7.3.4 Design and development review - Could simply state how often and at what points your organization would like to review the design. If it's only a change to an existing design as you described then these reviews could be stated as intital review and final sign-off. That is up to you and your business needs.

7.3.5 Design and development verification - Could state how the changes will be tested and validated as necessary. If a protocol needs to be written or not. Your company can describe at what level or point an protocol would even need to be completed, however, anything you cannot measure should be validated.

Risk management could be handled the same way. You could require a design FMEA and a process FMEA as your risk plan. ISO is trending to a risk review before committing to a design or a change. But you would have to assess your level of need for risk assessment based on the type of product you have.
 
A

Alice kazu

Registered
#16
#16
rlbate said:
Il y a beaucoup de choses à considérer, cependant, pour commencer, (...)
7. Quelqu'un a-t-il un exemple pratique de vérification de la conception dans le secteur des implants orthopédiques (plaques et vis) ? Si vous m'envoyez votre adresse e-mail, je serai plus qu'heureux de vous envoyer quelques exemples et idées.

rabais
[email protected]
Click to expand...

Bonjour, êtes-vous toujours active sur le forum ? Je suis ingénieure débutante en R&D dans une entreprise qui réalise du développement d'implant orthopédique et j'aurai quelques questions à vous poser à ce sujet.

Cdt,
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Risk-based approach to Test Method Validation for Design Verification? US Medical Device Regulations 4
K Design: Verification Vs Validation And Validation Vs Transfer ISO 13485:2016 - Medical Device Quality Management Systems 19
J Design Input Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Use of Statistical Techniques in Design Verification Design and Development of Products and Processes 18
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
J Design Verification Testing and Statistics Reliability Analysis - Predictions, Testing and Standards 3
C Items used for Design Verification Design and Development of Products and Processes 7
J Managing design verification regression testing of design changes Design and Development of Products and Processes 1
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 5
C Stress / Challenge Conditions for Design Verification Testing to Reduce Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
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 6
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
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
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
D Design Verification - Is testing required? Design and Development of Products and Processes 5
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 21
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
D Supplied item design verification Supplier Quality Assurance and other Supplier Issues 5
Ronen E A Rational Basis for Design Verification Design and Development of Products and Processes 5
V Which batches should or could be considered for design validation and design verification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
E Sample size for design verification of variable in single use device Design and Development of Products and Processes 20
S Source of QMS templates including templates for design verification/design validation Document Control Systems, Procedures, Forms and Templates 2
C Deviation in Design verification Other Medical Device Related Standards 6
V Using K-Factor(Tolerance Interval) Analysis for Design Verification Statistical Analysis Tools, Techniques and SPC 3
J Design Verification - Managing Changes Design and Development of Products and Processes 4
S CE Mark Approval Design Verification and Validation Questions CE Marking (Conformité Européene) / CB Scheme 8
V Template / format for Device History File & Design Verification of transdermal patch 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
H Is design verification and validation required for samples accompanying the quotes ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Pre-Design Verification - Using Continuous / Variables Data Statistical Analysis Tools, Techniques and SPC 2
W Qualification of Design Verification Equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Design Verification: "Difference" in Sample Size Calculations? Design and Development of Products and Processes 1
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
H Form that will satisfy Design Review and Design Verification Requirements (7.3) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Design Inputs and Verification Activities CE Marking (Conformité Européene) / CB Scheme 5
R Need help on defining scope for Design Verification File for Class III IVD 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
smryan Satisfying the ISO 9001:2008 7.3.5 Design & Development Verification requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Uriel Alejandro Trouble with a Mechanical Design Technical Verification Check List AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Design and Development Outputs Approval, Verification and Validation IATF 16949 - Automotive Quality Systems Standard 4
A ?820.30(d) Design Output Release - Before or After Verification? Design and Development of Products and Processes 6
T DVP&R (Design Verification Plan and Report) for Vehicle Labels? APQP and PPAP 3
W Design History Verification Records Control and Approvals US Food and Drug Administration (FDA) 3
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
S Design and Development - Review vs. Verification vs. Validation Design and Development of Products and Processes 15
S Acceptance Criteria at Design Verification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2

Similar threads

Top Bottom