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Contradictions in Medical Device Verification vs. Validation - ISO 13485

S

seywerd

#31
#31
Back to devices, rather than processes:

I believe I understand the concept of verification. A specification is prepared and a test is designed that indicates that the device meets this specification (or not as the case may be).

Various people have stated that validation is ensuring that the device meets customer requirements or that the correct device is being built.
1) How is one supposed to do this other than specifying a set of tests, i.e. a means to collect objective evidence. What other sort of objective evidence would be appropriate?
2) If a device is supposed to be validated before being put on the market and used than how does one know if it meets customer requirements?

One way I have thought about this, and I wonder if I am correct is:
1) Specify a device to have certain performance characteristics - these are public specifications rather than internal ones.
2) Verify that these specifications are met.
3) Assuming that the performance specifications were correctly chosen, then validation is complete.

Does this make sense??
 
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T

tata347

#32
#32
If you are the medical device specifier then YOU (your multi-departmental team) are the ones who determine what the specification should be. In the case of a medical device, you may perform clinical testing to make sure (futher) validate the device before submitting the 510K or putting on market.

Many of the posts in this thread refer to the "customer" because we are building products for someone else (OEM) who has specified the verfication (testing) parameters.

If you are the company who designed it, the assumption is that someone / marketing research has shown that the users (may be customers) may want the product. For example you wouldn't just manufacture a round surgical tray unless your sales & marketing group had determined that there was sufficent need.

This however is a common conflicting question.. who are your customers? it could be the doctors & hospital staff or the patient (we call this the end user) or the first person in the line who writes you the PO & check. hope that helps.
tata :frust:
 
R

Roland Cooke

#33
#33
For many of the high-risk devices I see, design verification and design validation are essentially indistinguishable.

Take condoms for example. Under most regulatory schemes condoms are high-risk devices, and thus design control cannot be excluded from the company's QMS.

Condom manufacturers are forever coming out with new presentations of the device. Often this is just packaging, but can often be new shapes, new lubricants, new flavours, etc etc.


But the materials of choice have almost always already been developed (usually natural rubber latex, but there are also polyurethane and a few other materials also used). And the new lubricants and flavours are rarely new either. So there usually isn't much design work required there.

Additionally clinical performance - the oft-quoted example of design validation - has been produced in abundance for condoms. Unless there is something really freaky about the new variant, there won't be a need for additional clinical effectiveness testing.

Finally there are well-established international standards for performance. (e.g. ISO4074:2002.)

So by demonstrating that the prototype of the new device is not much different from existing versions, and that it meets the appropriate physical/chemical requirements, not only is the design verified, but it is pretty much validated also.


Conversely, I see plenty of low-risk devices where it is easy to prove the design is verified - after all, the prototype accurately matches the engineering drawings.

But the information that shows that the new device is safe and effective in actual use - i.e. that the design is validated - well that is often missing....
 
A

Al Rosen

Staff member
Super Moderator
#34
#34
Roland Cooke said:
For many of the high-risk devices I see, design verification and design validation are essentially indistinguishable.

Take condoms for example. Under most regulatory schemes condoms are high-risk devices, and thus design control cannot be excluded from the company's QMS.

Condom manufacturers are forever coming out with new presentations of the device. Often this is just packaging, but can often be new shapes, new lubricants, new flavours, etc etc.


But the materials of choice have almost always already been developed (usually natural rubber latex, but there are also polyurethane and a few other materials also used). And the new lubricants and flavours are rarely new either. So there usually isn't much design work required there.

Additionally clinical performance - the oft-quoted example of design validation - has been produced in abundance for condoms. Unless there is something really freaky about the new variant, there won't be a need for additional clinical effectiveness testing.

Finally there are well-established international standards for performance. (e.g. ISO4074:2002.)

So by demonstrating that the prototype of the new device is not much different from existing versions, and that it meets the appropriate physical/chemical requirements, not only is the design verified, but it is pretty much validated also.


Conversely, I see plenty of low-risk devices where it is easy to prove the design is verified - after all, the prototype accurately matches the engineering drawings.

But the information that shows that the new device is safe and effective in actual use - i.e. that the design is validated - well that is often missing....
Click to expand...
Interesting choice for an example. What clinical performance is done? :lmao:
 
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