Design Change needed for Changing an Angle in existing Product from 15-25 degrees?

C

Cinti

#1
Hi

We designed a product and selling in the market for the past 3 years. Now we would like to include one new model by changing angle from 15 to 25 degree. For this change, is it required to have design change?

Can anybody briefly explain me with example about design change

Cinti
 
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G

Gert Sorensen

#2
Re: Design Changes

Can you please elaborate a bit about what the product actually is?
 
D

ddunn

#3
Re: Design Change needed for changing an angle in existing product from 15-25 degrees

Changing from 15 to 25 degree sound like a rather significant change. Will the change violate the rules of interchangeability? That is, can the new part be used in place of the old part without consideration of form, fit or function. If the new part is not interchangeable with the old part then it is not a design change. A new part number is required.
 
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D

DrM2u

#4
Re: Design Change needed for Changing an Angle in existing Product from 15-25 degrees

I am not sure that I understand ... Are you creating a new product based on the design of an existing product or are you changing the design on an existing product to a new revision? A new product will most likely follow the requirements and guidelines of ISO 9001 clause 7.3 or whatever new product desing process you might have. You would have to control the design change through your internal change management process/procedure.
 
T

trainerbob

#5
Re: Design Change needed for Changing an Angle in existing Product from 15-25 degrees

If the change affects form, fit, or function in any way, it is a new product and subject to 7.3. It sounds like a considerable change in the product - probably more than just a rev level change. I guess I have asked the question before - "Why do people have a difficult time doing what they should do?"
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Design Change needed for changing an angle in existing product from 15-25 degrees

Changing from 15 to 25 degree sound like a rather significant change. Will the change violate the rules of interchangeability? That is, can the new part be used in place of the old part without consideration of form, fit or function. If the new part is not interchangeable with the old part then it is not a design change. A new part number is required.
:nope:

In medical devices the key measures are "safety and efficacy", not interchangeability. I would say that if such a change affects either safety or efficacy, in the context of intended use, then it is a significant design change. Otherwise it may be not. it doesn't matter how much was an angle changed; it only matters if this change affects safety and/or efficacy.
 

somashekar

Staff member
Super Moderator
#7
Re: Design Change needed for Changing an Angle in existing Product from 15-25 degrees

Hi

We designed a product and selling in the market for the past 3 years. Now we would like to include one new model by changing angle from 15 to 25 degree. For this change, is it required to have design change?

Can anybody briefly explain me with example about design change

Cinti
One new model (varient) is an other new product which will have its unique identification. Your first design will support this with a justification for a varient with the new changed angle. There are so many varients in say for example urinery cathethers and gastroentrological cathethers and drain pipes and not much change happens in them but for some length / dia / loop / angle, etc.
 
C

Cinti

#8
Re: Design Change needed for Changing an Angle in existing Product from 15-25 degrees

The product i am referring here is the surgical blades. There is a specification change in grinding process to make blades to 25 deg. We have specification for 15 deg. New models contains 25 deg.

For this change, shall i initiate design change process?
 

somashekar

Staff member
Super Moderator
#9
Re: Design Change needed for Changing an Angle in existing Product from 15-25 degrees

The product i am referring here is the surgical blades. There is a specification change in grinding process to make blades to 25 deg. We have specification for 15 deg. New models contains 25 deg.

For this change, shall i initiate design change process?
Please do not.
As the 15 deg blade continues to be also made, this is not a design change process.
Consider the input of why a new varient angle surgical blade was received and how you deduced that 25 deg meets the requirement, and maintain a new design master record in which all but this said above will be included and rest remains same as the 15 deg design master record.
 
T

tbsiva

#10
Re: Design Change needed for Changing an Angle in existing Product from 15-25 degrees

If you are going to stop the production of 15 deg and only going to continue with 25 deg - with change in existing drg, we can consider this as a design change. If both parts will be running, then carryout the minimum activities which are required for 25 deg blade considering it as a different part altogether.
 
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