Design Validation of class 2 medical device - Vertebral Body Replacement

M

maxwell

#1
Greeting Everyone:

I am wondering how are medical device manufactures performing design validation for implants, in this case a class 2 device Vertebral Body Replacement device (intended for use in the thoracolumbar spine (T1-L5). Device has been tested to the required performance standards (design verification). FDA has approved 510K (As substantially equivalent) But I am unsure how to do design validation. Clinical or animal studies are not cost effective and have significant timeline constraints, I cannot find any computer simulation software program available. Any recommendations or comments you might have will be greatly appreciated.
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#3
Maxwell,

Sorry I have not posted anything sooner. Honestly, though, I am not sure I have anything of interest to you.

Do you take X-rays of the piece you are going to simulate? How do you come up with dimensions for making your part?

Will this be stainless steel, and do you have information regarding rejection rates of the material?

Anyway, possibly you could team up with a local university that has some simulation systems, and graduate students just looking for such a program.

If you have the input parameters (the size to manufacture it) and the tolerance/ specification you have for making it, with a 3 D system they could perform some simulations to develop best case, realistic, and worst case scenarios. Then within your worst case, you could justify the rejection possibility and patient impact.

This may be totally not feasible, but thought I would give it a try.
 
M

maxwell

#4
Brad M
Thanks for the information, The device is made from titanium ELI and meets ASTM F136 standard specification for implant applications. We have defined the inputs and outputs, Fabricated prints with dimensions and tolerances established. The prototypes have been manufactured and tested to FDA required performance standards and the device has been reviewed and approved (510k) by FDA. It's the design validation that I am having issues with.CFR 820.30 (G) Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.
 

BradM

Staff member
Admin
#5
.....shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.
I was just thinking maybe you could do some simulation studies with the human body and the device. Some of those simulation labs are amazingly detailed and precise. At least you would have something to support that the device was properly designed for it's intended purpose.

As bad as it pains me to say this, it might be worth contacting some validation consultants for this area. I would also be interested in seeing what level of design validation occurs with knee/hip replacements.

Sorry I could not be more help.
 
Thread starter Similar threads Forum Replies Date
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
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
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
C Design Transfer Review - Before or after PQ validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 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
T Sample Size for Design Validation Design and Development of Products and Processes 4
J Is Design Validation required for fixtures or test systems used to manufacture a product? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
S Source of QMS templates including templates for design verification/design validation Document Control Systems, Procedures, Forms and Templates 2
L Why is initial production units, lots, or batches, or their equivalents required for Design Validation? US Food and Drug Administration (FDA) 3
S Is Human Factor Testing required as part of Design Control Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
W Design and Process Validation - Different? ISO 13485:2016 - Medical Device Quality Management Systems 6
C Partial Design Validation and changes to a critical supplier 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Design Validation Conventions for Design History Files 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S CE Mark Approval Design Verification and Validation Questions CE Marking (Conformité Européene) / CB Scheme 8
J Design Control - Can Validation be based on a limited/first Production Run ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C MSA for Non Manufacturing - Design Validation, Characterization and Qualification Lab Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
N How to perfom Design Validation for Road Designs Design and Development of Products and Processes 14
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
T ISO 9001 - Design Validation Record exemption ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A Products for Design Validation - FDA Requirements US Food and Drug Administration (FDA) 3
S Can anyone provide an example of Design Validation Protocol and Report? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
H Is design verification and validation required for samples accompanying the quotes ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Verification and Validation of Post Market Design Change Design and Development of Products and Processes 2
A Determination of Production Equivalence for Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Chennaiite How to Measure Effectiveness of the Design Validation Process? Design and Development of Products and Processes 7
A Finishing Design Validation per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
K Medical Device Design Validation vs Clinical Evaluation ISO 13485:2016 - Medical Device Quality Management Systems 5
M Design and Development Validation at the Customer's Location Document Control Systems, Procedures, Forms and Templates 5
P How to separate Product Design Review, Verification, and Validation Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Design and Development Outputs Approval, Verification and Validation IATF 16949 - Automotive Quality Systems Standard 4
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
A How to do Medical Device Design Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
S Design and Development - Review vs. Verification vs. Validation Design and Development of Products and Processes 15
G Sample Size for Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
L Design Validation Process Owner - Who should be the process owner of validation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Is Ship Test considered Design Verification or Design Validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Design Input/Output and Design V&V (Verification and Validation) Interpretations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
D Medical Device Design Verification and Validation Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 16
Chennaiite Prototype - Design Verification or Validation? APQP and PPAP 12
B Validation of DoE (Design of Experiements) Model - Minitab 15 Using Minitab Software 3
T Design Validation - Justifiable Exclusion for an Electrical Engineering Consultancy Design and Development of Products and Processes 11
I Cumulative Confidence Levels - Design Verification and Validation Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
B Sample Sizes for In-Vivo Design Validation Testing Other Medical Device and Orthopedic Related Topics 1
S Medical Device Design Verification and Validation - info Other Medical Device and Orthopedic Related Topics 1
S Design Validation Work Instruction - Help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Special 510k - Data Results of the Design Verification and Validation Other US Medical Device Regulations 3

Similar threads

Top Bottom