CE Mark Approval Design Verification and Validation Questions

[Sandeshgk7]

Hello all,

I need a help regarding Design verification protocol

Right now we are working on a product for CE approval.

Our product have in-house manufactured and bought out CE approved parts, My questionis
1) While writing verification steps for the complex requirement of bought out parts is it acceptable to refer the user manual or product spec document and the qualify the requirement or do we really need to inspect the product to qualify the requirment requirement ?

2) Please share an example of validation and verification protocol?

Thanks in advance

 

[Ronen E]

What kind of product are we discussing? Is it a medical device?

 

[Sandeshgk7]

Hello Ronen E

Yes it is medical device, Radiography device in particular.

 

[Ronen E]

Hello all,

I need a help regarding Design verification protocol

Right now we are working on a product for CE approval.

Our product have in-house manufactured and bought out CE approved parts, My questionis
1) While writing verification steps for the complex requirement of bought out parts is it acceptable to refer the user manual or product spec document and the qualify the requirement or do we really need to inspect the product to qualify the requirment requirement ?

2) Please share an example of validation and verification protocol?

Thanks in advance

Hi,

If a requirement you are verifying is met by an off-the-shelf, CE marked product alone, without interaction with other parts, and that characteristic is also in that product's specification, I would say it would suffice to refer to the original product (component) specification in your verification. In all other cases you should probably run a test.

Cheers,
Ronen.

 

[Sandeshgk7]

Thank you for your valuable answer.

I have query regarding validation protocol

i am using below format to write the test cases for Design validation

Column No 1 User need ID
Column No 2 User need Statement
Column No 3 Verification method ( Inspection,test,demonstration etc)
Column No 4 Acceptance criteria
Column No 5 Verification Method
Column No 6 observed results


My question is

Do i need to write the detailed step by step Work Instructions for validating the user need in the column no 5 or can i take out that column ?

Really help full if you could share any example verification and validation protocol with similar information


Thanks in adavance

 

[Ronen E]

I have 3 comments:

1. Form doesn't matter as long as the essential information is communicated clearly.
2. I think you are confusing verification and validation.
3. Yes, you need to include detailed test instructions in the validation protocol (and also in verification protocols).

 

[Mark Meer]

Hi Sandeshgk7,

Verification and validation have been discussed a lot on this forum, but I'll try to summarize here as best I can with some simple examples.

Design Verification
Design verification activities should output documented evidence that design requirements are met. For example:

• Design input requirement: "Device shall measure 4cm +/- 0.5cm in length"
• Design verification plan: "Use calipers to measure the length of the device, Acceptance criteria: measurement is 4cm +/- 0.5cm"
• Design verification output: "EUT Pass. Measured length: 4.1cm"

Design Validation
Design validation activities should output evidence that the product does what it's supposed to, typically involving representative subjects using the device in actual or simulated use conditions. For example (say the product is instant rice):

• Product requirement: "Users should be able to follow instructions and cook the rice"
• Validation plan: "Select X subjects, have them read and follow the instructions. Inspect the resulting rice to see how well it's cooked on a scale of 1 (uncooked) - 3 (perfectly cooked)".
• Acceptance criteria: Average result is 2.75 or higher.

Hope this helps somewhat.
If you want more details, I'd suggest searching this forum for discussion threads on verification and validation.

Good luck!
MM

 

[Ronen E]

Mark's post above is a good intro. I'd like to add some comments (in no way intended to fully cover the subject):

1. Design verification is about comparing the design output (product specifications and actual products) with the design input (design engineering requirements), while design validation is about checking the final product against the user needs/requirements in a real-life or simulated environment.

2. Design verification is typically about demonstrating compliance while design validation is about proving compliance.

3. Both need to address statistical considerations. Protocols must specify sample size and should address sampling strategy and analysis methods. Item #2 above implies that validations require more rigorous statistical methods than verifications (this is true also because many times validations try to address more "fluid" or subjective requirements)

4. Validations should show that requirements will be consistently met - that means accounting for variability and noises in the environment (including users) and in the product itself.

 

[Sandeshgk7]

Hello Mark Meer

I have one more question for you.

As per out previous discussion we don't need to verify the requirements of the CE approved parts during verification, just refereeing to product specification is sufficient.

My question is

1) Do we really need validate the user needs of CE approved parts?

2) If we don't need to validate them ,then what needs to written in the validation method column ( Detailed work instruction) column? i,e How to write work instruction steps to say that product spec meets the specified user need?

Please use below examples.

1) Radiography generator shall be able to produce high frequency voltage.
2) Maximise the image resolution of the X-Ray.